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FDA Issues Recall For CareFusion EnVe and ReVel Ventilators

Author Jarod Cassidy

On October 10, 2014, the U.S. Food and Drug Adminsitration (FDA) announced a class 1 recall of certain CareFusion 203 manufactured ventilators.

The EnVe ventilator produced by CareFusion is marketed as a small, mobile ventilator, which can be used when moving patients around the hospital. While the ReVel ventilator is marketed as a lightweight ventilator to be used while transporting the patient to the hospital.

A ventilator is used to help patients to breath when they either have trouble breathing or cannot breath on their own.

FDA Warns Use of Recalled EnVe and ReVel Ventilators Could Cause Death

The FDA warns that damage can occur to the power cords and adaptors on the EnVe and ReVel ventilators leading to a complete shut off of the ventilator.

StreetInsider reports the pins in the power cord do not always line up correctly, leading to damage, which can ultimately cause a short circuit and prevent the batter from functioning.

The FDA warns that the ventilator shuting off can lead to serious injury or death. The FDA only issues class 1 recalls when it feels that use of the recalled product has a reasonable chance of causing severe injury or death.

Qmed, a medical device supplier, reports that the FDA has received 256 reports of the EnVe and ReVel ventilators shutting off. The FDA states the affected CareFusion ventilators were manufactured between May 2009 and August 2014, according to BioSpace. The FDA has not yet posted a list of the recalled lot numbers.

Continued Troubles for CareFusion

BioSpace reports that this is the 11th class 1 recall, the most serious class of recall, for CareFusion products since 2012. Qmed reports the other ten recalls are the following:

  • May 20, 2014 > Alaris Pump Module (Model 8100), Version 9.1.18
  • October 21, 2013 > CareFusion 211 Inc Avea Ventilators, all models
  • August 7, 2013 > Alaris PC unit (model 8015) with version 9.12 Keyboard Processor
  • April 22, 2013 > Alaris PC unit (model 8015) with Software Version 9.12
  • August 23, 2012 > Alaris Pump Module, Model 8100 Motor Stall
  • August 22, 2012 > Alaris Pump Module, Model 8100 Keyboard Overlay
  • August 1, 2012 > Alaris PC Unit, model 8015
  • July 20, 2012 > EnVe Ventilators
  • July 6, 2012 > CareFusion Airlife Infant Breathing Circuit
  • February 22, 2012 > NicoletOne Software Used with Cortical Stimulator Control Unit

Forbes reports that CareFusion, which is being acquired by BD, a medical device maker, for $12 billion, settled with the federal government over criminal charges alleging CareFusion paid kickbacks to doctors and illegally marketed its products.

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16-Year-Old Texas Resident Faces Vehicular Manslaughter Charges

Author Danielle Dougall

A 16-year-old resident of Odessa, Texas faces manslaughter charges after crashing his vehicle and killing his passenger on impact.

About the Automobile Accident

Reports indicate the driver responsible for the crash was said to be driving a Ford F-150 and was traveling at a rate of 98 mph before the two-vehicle accident occurred. The victim, 16-year-old Hunter Miller, the passenger in the pickup, died shortly after the accident occurred from his resulting injuries.

A third driver, a 15-year-old girl was also said to be present in the accident but was not involved in causing the crash.

According to the Odessa Police Department, a person is considered to be an adult at the age of 17 in Texas, but it is unclear if the teen will be charged as an adult or a juvenile. If tried as an adult, he could face up to 20 years in prison.

The parents of the driver responsible for the accident could not be reached for a statement.

Texas Car Crash Statistics

The following information was provided by the Texas Department of Transportation (TxDOT):

  • 3,377 people were killed in auto accidents in Texas in 2013.
    • 1,883 deaths were attributed to crashes that occurred in rural areas.
    • 767 people were killed in crashes involving intersections.
    • 523 people were killed in head-on collisions.
  • Another 232,041 people were in auto accidents with 89,270 people sustaining serious injuries.

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2 Dead in Wrong Way Collision

Author Brigitte Barrera

A wrong way accident left two people dead and one seriously injured Saturday morning.

About The San Antonio Accident

According to the San Antonio Express-News, the accident occurred in the west side of San Antonio on the 10300 block of U.S. 90.

Ana Wright, 46, was driving eastbound in the westbound lanes of U.S. 90 when her SUV hit another car, driven by Allen McEntyre, 48, before striking a third vehicle, a silver Lexus.

Wright’s SUV and McEntyre’s car both burst into flames following the collision. McEntyre and Wright were pronounced dead at the scene.

The driver of the Lexus sustained critical injuries and was taken to University Hospital.

Officials believe that intoxication is a factor in the accident.

Texas Auto Accident Statistics

The following information was provided by the Texas Department of Transportation (TxDOT):

  • 3,377 traffic related fatalities were recorded in Texas in 2013 – a 1.05 percent decrease from the 3,413 deaths recorded in 2012.
  • 523 of those deaths were attributed to head-on collisions.
  • 1,089 people were killed in collisions in which at least one driver was under the influence of alcohol.
  • 232,041 people were injured in auto accident in Texas in 2013.

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