ALERT-ZOLL LIFEVEST 4000 WEARABLE CARDIOVERTER DEFIBRILLATOR

ALERT – FDA

DE FAAKTO INTELLIGENCE RESEARCH OBSERVATORY

SITUATION-UNITED STATES FOOD & DRUG ADMINISTRATION SAFETY COMMUNICATION

ZOLL LIFEVEST 4000 WEARABLE CARDIOVERTER DEFIBRILLATOR

SOFTWARE UPDATE FOR POTENTIAL LACK OF TREATMENT (SHOCK) DELIVERY DUE TO DEVICE FAILURE

BACKGROUND-The Zoll LifeVest 4000 is a wearable defibrillator used to treat life-threatening abnormal heartbeats (arrhythmias) in adults and children who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator. The LifeVest continuously monitors the patient’s heart and, if a fast, life-threatening heart rhythm is detected, the device delivers an electrical shock to restore the patient to a normal heart rhythm. The LifeVest 4000 is the only wearable cardioverter defibrillator currently available in the United States. (FDA)

 

RECOMMENDATIONS

  • Contact Zoll right away if the “Call for service – Message Code 102” alert appears on your LifeVest 4000 screen
  • Zoll’s Customer Service can be reached 24 hours a day, and 7 days a week at: 1-800-543-3267
  • The “Call for service – Message Code 102” alert means that the LifeVest 4000 might have a serious problem and the device might not deliver a life-saving shock if needed
  • Zoll will replace your device within 24 hours, for free, if the device displays “Message Code 102 ”
  • Continue to use your LifeVest while you wait for the replacement. Even if the “Call for service – Message Code 102” alert appears, the device may still be able to deliver a life-saving shock to restore normal heart rhythm, if needed  (FDA)

 

FDA DETAILED ALERT  https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm632783.htm?utm_campaign=LifeVest%204000%20Wearable%20Cardioverter%20Defibrillator%20by%20Zoll%3A%20Safety%20Communication&utm_medium=email&utm_source=Eloqua