ALERT-DEFIBRILLATOR FAILURE LOCK UP LIFEPAK 15-STRYKER

DE FAAKTO ALERT

02 FEBRUARY 2019

ALERT INTELLIGENCE

U.S. FOOD & DRUG ADMINISTRATION

DEFIBRILLATOR FAILURE LOCK UP-LIFEPAK 15-STRYKER

  • Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK® 15 Monitor/Defibrillator
  • Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 Monitor/Defibrillators
  • The company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered
  • The lock-up condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions
  • A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death

 

Background

  • Since the initial commercialization of LIFEPAK 15 in 2009, Stryker has become aware of 58 complaints reported globally for this issue
  • 6 events in which the patient died following a delay in therapy
  • In all six of these cases, at least one shock was delivered prior to the device experiencing the lock-up condition
  • There are 13,003 devices potentially impacted by this issue and within scope of this field action

 

Stryker Website  http://www.strykeremergencycare.com/productnotices

FDA Website  https://www.fda.gov/Safety/Recalls/ucm630455.htm?utm_campaign=FDA%20MedWatch%20Recall%20Notice%20-%20LIFEPAK%C2%AE%2015%20Monitor%2FDefibrillator%20by%20Stryker&utm_medium=email&utm_source=Eloqua