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Over 50,000 Defibrillators Recalled, Unexpected Shut Down


On March 8, 2017, the FDA announced the recall of the LIFEPAK 1000 defibrillator. Physio-Control is recalling the LIFEPAK 1000 due to an electrical issue which may cause the device to shut down unexpectedly during patient treatment. Physio-Control has determined that wear and oxidation formation between the battery and device electrical contacts may cause power interruptions. This may prevent the device from delivering the electrical shock needed to revive a patient in cardiac arrest. A delay in delivering this therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.

 

The LIFEPAK 1000 defibrillator is used to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Defibrillation electrodes are attached to the patient and then connected to the defibrillator to help the device analyze a patient’s heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed. The LIFEPAK 1000 defibrillator is intended for use by medical professionals who are trained in CPR.

 

This recall affects 50,046 defibrillators nationwide. Affected defibrillators carry the part number 320371500XX. There are 133,330 affected serial numbers. Recalled defibrillators were manufactured between June 30, 2006, and December 20, 2016. Recalled defibrillators were distributed between June 30, 2006, and December 23, 2016.

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the FDA Recall

 

See the FDA Safety Alert

 

See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues

 

See also Medical Law Perspectives, February 2013 Report: Emergency Medical Services: Liability and Immunity for Medical Rescue

 

 

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