ALERT-UPDATE-DEFIBRILLATOR FAILURE LOCK UP LIFEPAK 15-STRYKER

28 FEBRUARY 2019

DE FAAKTO ALERT 

ALERT INTELLIGENCE

U.S. FOOD & DRUG ADMINISTRATION

UPDATE DEFIBRILLATOR FAILURE LOCK UP-LIFEPAK 15-STRYKER

 

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death

  • Physio-Control’s LIFEPAK 15 Monitor/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 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 15 monitor displays the patient’s heart rhythm so the health care provider can study the heart’s electrical activity
  • The LIFEPAK 15 is designed to be used only by trained medical personnel during ground transport of a patient  (FDA)

Reason for Recall

  • Physio-Control is recalling its LIFEPAK 15 Monitor/Defibrillator because the device may “lockup” (freeze) after a shock is delivered. When this occurs, the device’s monitor display goes blank and there is no response from the keypad or the device although the device’s LED lights remain on and indicates the device still has power
  • Once the LIFEPAK 15 freezes, it cannot provide defibrillation therapy until the device is reset by restarting the device or removing and reinserting all connected power sources. The resulting delay in delivering a shock could and has resulted in serious patient injury including death  (FDA)

 

FDA  https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm632203.htm?utm_campaign=FDA%20MedWatch%20Alert%20LIFEPAK15%20by%20Physio-Control&utm_medium=email&utm_source=Eloqua

 

 

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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