Tag Archives: News

Datascope recalls certain Intra-Aortic Balloon pumps.

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Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold by Datascope Corp. for a potential electrical test failure code.

AFFECTED PRODUCT PART NUMBER
CS100i IABP 0998-UC-0446HXX; 0998-UC-0479HXX
CS100 IABP 0998-00-3013-XX; 0998-UC-3013-XX
CS300 IABP 0998-00-3023-XX; 0998-UC-3023-XX

This field correction also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP.

Overall Action for User
Patients receiving IABP therapy are in critical condition and sudden interruption of therapy could result in unsafe, hemodynamic instability. Maquet/Getinge indicates that the risk-benefit of using an affected CS100i, CS100 or CS300 IABP should be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available. Please adhere to the following instructions when using affected devices:

  • Pursuant to the USER Instruction WARNINGS, clinicians are instructed not to leave the patient unattended during IABP therapy.
  • An additional hazard associated with a sudden shutdown is related to the static condition (no inflating or deflating) of the balloon during the interruption of therapy. It is important to note the following WARNING in the CS100i, CS100 or CS300 IABP Operating Instructions Manual:

    WARNING: The patient balloon should not remain inactive in the patient (i.e., not inflating or deflating) for more than 30 minutes due to the potential for thrombus formation.

  • Until the service is performed, we recommend powering on the IABP prior to inserting the IAB catheter to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform. In the event the IABP fails to successfully complete the self-test and exhibits electrical test failure code 58, please remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office.

Datascope has received a complaint that has been associated with a patient death due to the failure of the device to initiate therapy. This complaint involved a CS300 IABP that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure. An electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve.

There are approximately 12,000 affected units sold globally. The affected IABP units were distributed in the U.S. and worldwide (in over 100 countries). Affected units were distributed between March 23, 2003, and December 11, 2013. Units distributed after December 11, 2013, are not affected by the field correction.

A service representative from Datascope will be replacing the defective solenoid driver boards. Customers having affected IABP unit(s) will be contacted by a representative of the Maquet/Getinge Service Team to schedule on-site service.

For additional information regarding this field correction, please contact the Customer Service Department at 1-888-627-8383 and Press 2 (Monday through Friday from 8:00 a.m. to 6:00 p.m. EDT).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Agencies to conduct aerial survey of wild burros in North Valley

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AZGF Photo

PHOENIX — The Arizona Game and Fish Department (AGFD), the U.S. Bureau of Land Management (BLM), and the U.S. Geological Survey (USGS) will partner on an aerial survey of wild burros in and near the Lake Pleasant Herd Management Area beginning June 19.

Residents and recreationists in the North Valley area may see or hear a small, low-flying aircraft near Lake Pleasant and in areas east of I-17 between Anthem and Black Canyon City, south of Carefree Highway and the Loop 303 freeway; and west to areas near Morristown and Wickenburg.

“The main goal of these efforts is to ensure healthy ecosystems along with a safe environment for the public, employees, and public land users. Limiting the number of animal encounters with people and motor vehicles through better management of wild burro populations in our state can help achieve this goal,” said BLM Phoenix District Manager Leon Thomas.

The survey is part of ongoing research studies to collect information to guide future management of wild burros in Arizona. These studies are part of vital partnership efforts between the BLM and state agencies to address the issue of overpopulation of wild burros in the state.

The aerial survey may take up to six days, during which the agencies will work to record the number and location of burros observed along pre-designated flight paths. Related to this survey, the AGFD is also embarking on a three-year study to evaluate the effects of burros on Arizona’s wildlife and their habitat. Information gained will further help inform the BLM’s management of wild burros in herd management areas.

Finding right outdoor skills event is a lot easier

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PHOENIX — When it comes to choosing a “how-to” outdoor skill event, one size does not fit all.

So, where does one begin? Look no further than the Arizona Game and Fish Department, along with its extensive network of partnering organizations, which offers dozens of events throughout the year to suit almost everyone’s needs through the Outdoor Skills Network.

Those events now appear in a new format, organized based on skill level and interest:

  • Introductory: No hunting or pursuit of wildlife, shooting lessons, instructional, typically one-day activity. Introductory – knowledge or information imparted.
  • Beginner: Basic take of wildlife, one-day event, pass shooting, species include dove, ducks, squirrel. Beginner – a person who is inexperienced, novice, a person who has begun a course of instruction or is learning the fundamentals.
  • Developing: Pursuit of wildlife, overnight events, remote locations, species include quail, rabbit, predators, javelina, turkey. Developing – one who is learning by practical experience under skilled workers of a trade, art or calling.
  • Intermediate: Pursuit of more challenging species, deer, elk, stalking, remote locations, overnight, a lot of field time. Intermediate – applies some already learned basic skills to adapt and meet the next level of learning, skill development.
  • Experienced: Coming soon, minimal mentoring, base camps and “meet-ups.” Experienced – having knowledge or skill in a particular field, especially a profession or job, gained over a period of time.

“We are really excited with this new format,” said Doug Burt, the department’s hunting and shooting sports program manager. “We hope it’s better for the customer to find what’s right for them.

The new format can be found on pages 24-29 of the “2017-18 Arizona Hunting Regulations” and by visiting www.azgfd.gov/OutdoorSkills.

In an ongoing effort to better serve the public, the department recently launched a new online registration system. It’s a winning combination that’s customer-focused and mobile-friendly, as well as a time-saver.

Of course, event types and descriptions are merely guidelines. Most events offer activities that are suitable for all skill levels, from hunting, fishing and shooting to learning more about wildlife, habitat and conservation.

“In the end, we want the attendee to have the right expectations and the right experience,” Burt said. “That’s the key to keeping folks engaged in hunting and traditional outdoor recreation activities.”

There is no cost to Arizona taxpayers for this program. Game and Fish does not receive any of the state’s general tax funds and operates under a user-pay, public-benefit model. The program is an investment in the continuance of wildlife conservation efforts and outdoors recreation participation in Arizona.

To learn more about how hunters, anglers, shooters and boaters fund wildlife conservation, visit www.azgfd.gov/h_f/federal-aid-cycle.shtml.

Wind shift may relieve Flagstaff of smoke from Boundary Fire

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WILLIAMS – Overnight light north winds pushed smoke into some communities around Flagstaff with most of the smoke dispersing before dawn. As Sunday progresses, northeast winds are expected to push smoke toward Williams and Bellemont. Individuals sensitive to smoke may want to stay indoors to avoid smoke impacts.

Firefighter, public safety, and ecosystem health remain the top priorities for fire managers while keeping the fire within the planning area. Smoke continues to affect Highway 180, especially at night, and may impact I-40 and SR 64 tonight. Travelers are urged to use caution when traveling in and around the fire area.

Aerial ignitions will continue today and into the week on Kendrick Mountain. Ground crews continue to conduct hand ignitions near and around private property. Ignitions will be applied slowly to prevent high intensity fire and to minimize smoke effects to communities and highways.

Kaibab National Forest (map) and Coconino National Forest have instituted Stage 1 Fire Restrictions as of June 15, 2017, at 8:00am MST.

The following trails in the closure area are closed: Pumpkin Trail, Kendrick Mountain Trail, Bull Basin Trail, Slate Mountain Trail, Kendrick Watchable Wildlife Trail, and the 4th Connector Trail. While the Red Mountain Trail is open, it can only be accessed from the valley end of the Highway 180.

July 30 is deadline to apply for Local Sportsmen’s Group grants

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PHOENIX – The Arizona Game and Fish Department is accepting applications for $75,000 in annual grant funding for local sportsmen’s organizations to provide public, hands-on projects focused on the retention of new hunters and anglers.

The priority funding focus of this year’s Local Sportsmen’s Group grants program is on hunter-angler development and retention through progressive skill development. A new category has been added for projects that provide a base camp or “meet-up” for experienced hunters or anglers from past projects who no longer need mentored training. These are individuals seeking social support, defined times, destinations and gatherings.

Projects and events that involve the pursuit or harvest of wildlife or fish with a license are being requested. Grants will be awarded through a competitive application process and must be open to the public.

Doug Burt, the department’s hunting and shooting sports program manager, said there are many local organizations that do great work, but lack the funding to carry out the important mission of passing down the hunting and angling heritage to the next generation of wildlife conservationists and stewards.

“This grant program is an investment in local organizations that, day in and day out, are teaching people how to be safe, ethical and responsible hunter-angler conservationists,” Burt said.

To apply, download an application packet from https://www.azgfd.com/hunting/grant-program/. Completed applications should be submitted by e-mail to dburt@azgfd.gov, or mailed to Arizona Game and Fish Department, IEWR, Attn.: Local Sportsmen’s Grant Administrator, 5000 W. Carefree Highway, Phoenix, AZ 85086. Applications must be received no later than 11:59 p.m. (Arizona time) July 30, 2017. Postmarks do not count.

There is no cost to Arizona taxpayers for this grant program. Game and Fish does not receive any of the state’s general tax funds and operates under a user-pay, public-benefit model. The grant program is an investment in the continuance of wildlife conservation efforts and outdoors recreation participation in Arizona. To learn more about how hunters, anglers, shooters and boaters fund wildlife conservation, visit www.azgfd.gov/h_f/federal-aid-cycle.shtml.

Boundary Fire continues to burn fuels

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WILLIAMS – Warmer and dryer weather conditions are expected over the weekend which could slow progress on the Boundary Fire, as fire crews work slowly and methodically to back the fire down the mountain. This will allow for better control reducing the chances of the fire front pushing uphill and creating intense heat which would adversely affect the tree canopy. It is important that fire crews continue with ignitions during dry weather as it allows for consumption of the decadent fuels on the ground, decreasing the heavy accumulation of fuels on the mountain. The window of opportunity to be able to reduce fuel loads in this area is limited to the time between when the fuels dry out from winter snow melt and the Monsoon rains. Therefore, timing is everything.

Every year Kendrick Mountain sees multiple fire starts. By allowing this fire to reduce the hazardous fuels that exist there currently, we are setting ourselves, our neighbors and our communities up for less risk from those starts in the future.

Today, aerial ignitions continued adjacent to the historic cabin and Kendrick Lookout Tower. Helicopters were onsite assisting with water drops in the area. Ground crews began preforming hand ignitions near and around private property.

Expect increased smoke production over the next few days and poor air movement. Smoke may affect local communities including Greater Doney Park, Timberline, City of Flagstaff, Baderville, Fort Valley, and Bellmont. Firefighter, public safety, and ecosystem health remain the top priorities for fire managers while keeping the fire within the planning area.

Closure Order Number 04-17-14-F (PDF)) includes all or parts of Forest Roads 9005, 9023C, 91, 736, 144, 171, 193, and ending at US Highway 180 remains in effect. This closure includes all roads and trails within the perimeter of the closure area. US Highway 180 will also remain closed until further notice. For more information regarding highway closures please visit azdot.gov or visit ADOT’s Travel Information Site at www.az511.gov.

For more information on the Boundary Fire, visit inciweb.nwcg.gov/incident/5209/. Quick updates will also be provided via Twitter at @KaibabNF and @CoconinoNF. Please follow us if you would like to be updated as information is received.

Increased Smoke Production Expected While Crews Make Progress on the Boundary Fire

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WILLIAMS – Yesterday, aerial ignitions in conjunction with helicopters dropping water to moderate fire intensity of the 6278-acre Kendrick fire around the historic cabin and Kendrick lookout tower. Hand ignitions are planned around private property in the coming days once fire has reached a predetermined location in efforts to protect property and values at risk.

Fire will continue to work its way through timber stands consuming dead and down fuels along the forest floor minimizing impacts to tree canopies. Increased smoke production may occur over the next few days and poor ventilation predicted in the forecast may result in lingering smoke around the communities of Flagstaff, Kendrick Park, Whitehorse Hills, Timberline, Bellemont, Baderville, Cameron, and Tuba City. Firefighter and public safety and ecosystem health remain the top priority for fire managers while keeping the fire within the planning area.

An amateur radio operator reported that at the Flagstaff meeting last night, the Forest Service officials said they will investigate the possibility of smaller burns to reduce smoke.

The Kaibab Forest officials would like to remind people NOT to fly drones in the area of fires. Pilots only know if there is a drone in the area if they spot it. If they don’t, an impact can damage a helicopter. If the pilot spots a drone, the only thing they can do is land and wait. Please use drones responsibly.

Firefighters fight fire in Williams with helo

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Corrected 6/16/17 9:21 a.m.

WILLIAMS – With Stage 1 Fire Restrictions in effect as of 8 a.m. this morning, an amateur radio operator informed us of a fire began about 2 p.m. this afternoon in the area of the Williams Hiking Trail on the west side of Williams. The cause of the fire has not been released. All of this as a plume of smoke rose in the sky in the east from the Boundary Fire on Mt. Kendrick.

The area of fire appeared to be about an acre. A Chinook CH-47 helicopter with a Bambi Bucket was brought in and began dumping water from Santa Fe dam on the fire about 3 p.m. Firefighting efforts began to subside about 5:30

Stage I fire restrictions, will began today 8 a.m. across the entire Kaibab and Coconino national forests. The goal of the fire restrictions is to protect public health by reducing the number of preventable human-caused wildfires.
Under the restrictions, fires, campfires, charcoal, coal and wood stoves are prohibited, except within a developed recreation site. Smoking is also prohibited, except within an enclosed vehicle, building or a developed recreation site. Using a device that is solely fueled by liquid petroleum or LPG fuels that can be turned on and off is allowed in areas that are barren or cleared of all overhead and surrounding flammable materials within three-feet of the device. Fireworks are always prohibited on all national forest lands. The national forests use fire restrictions to help prevent unwanted, human-caused fires and to limit the exposure of visitors during periods of potentially dangerous fire conditions.

Implementation of fire restrictions normally occurs based on a combination of factors that are carefully measured. Criteria used to determine when to implement restrictions include things such as current and predicted weather, fuel moisture, fire activity levels and available firefighting resources. Additional restrictions may be applied as conditions warrant. An explanation of the different stages of fire restrictions and what is typically prohibited during those stages can be found online at tinyurl.com/firestagesexplained.

Fire restrictions typically remain in effect until the forests receive significant precipitation, at which time they will be rescinded.

Forest officials would also like to remind visitors that having a campfire on the national forest while under fire restrictions is a violation that carries a mandatory appearance in federal court. Visitors should use extra caution when recreating on all public lands during fire season.

Know Before You Go!
The public can obtain additional fire information via the following:
Arizona Fire Restrictions – www.firerestrictions.us/az/Arizona Interagency Wildfire Prevention and Information Website – www.wildlandfire.az.gov/
Fire Restrictions on Public Lands in Arizona and New Mexico-1-877-864-6985
Coconino National Forest – www.coconinonationalforest.us
Kaibab National Forest – www.fs.usda.gov/kaibab

Aerial Ignition Operations Begin on Kendrick Mountain

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WILLIAMS — Helicopter aerial ignition operations continue today near the Kendrick Mountain peak. The operations, in which incendiary devices are dropped from a helicopter to reduce dead and down fuels, began near the peak on Tuesday. The plan is to continue to use aerial ignition to bring fire slowly down the mountain. The tactics benefit the ecological conditions in the Kendrick Mountain Wilderness while minimizing impacts.

A community meeting in east Flagstaff (see above) on Thursday will provide information on the Boundary Fire and on potential impacts from smoke that may affect the eastern side of Flagstaff over the next several days. Health and emergency management personnel will also be on hand. Representatives of the Coconino and Kaibab national forests will discuss fire restrictions that take effect Thursday.

The meeting will be held at 6 p.m. Thursday, at the Summit Fire District, 6050 E. Firehouse Lane, Flagstaff.

For more information, details, visit inciweb.nwcg.gov/incident/5209/. Quick updates are available via Twitter at @KaibabNF and @CoconinoNF. Follow us if you would like to be updated as information is received.

Rescuers Respond to Calls for Hiking Fall Victims

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Pomeroy Tank Rescue

FLAGSTAFF – On Saturday June 10 at approximately 9:30 am the Coconino County Sheriff’s Office, Coconino County Sheriff’s Search and Rescue, Ponderosa Fire District, Lifeline Ambulance, Arizona Department of Public Safety Northern Air Rescue Unit, and Guardian Air Transport responded to a report of an injured adult male hiker who fell approximately 20 feet from a rock at Pomeroy Tanks near Williams.

Sheriff’s Office personnel and EMS personnel located the patient who was suffering from serious injuries. Due to the injuries and the location of the incident, a short haul rescue was performed and the subject was then transported to a waiting air ambulance.

The short haul rescue involved connecting the patient and a rescuer to a rope suspended 150 feet below the helicopter and then flying a short distance to an area suitable for transferring the patient to another helicopter for transport to the hospital. The patient, a 47-year-old male from Phoenix, was transported to Flagstaff Medical Center.

On Monday June 12, 2017 at approximately 8:30 am the Coconino County Sheriff’s Office, Coconino County Sheriff’s Search and Rescue, and Guardian Medical Transport responded to a report of a hiker who was injured in a fall in Walnut Canyon near the Canyon Vista Campground.

The adult male hiker was located by paramedics from Guardian Medical and assessed for injuries. Search and Rescue personnel hiked in with a litter and litter wheel to assist with a carry out o the patient to the ambulance at the trail head. The patient, a 63-year-old male from Carrollton, Texas, was transported to Flagstaff Medical Center with serious injuries.