MAUDE Adverse Event Report: ZOLL LIFEVEST; WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR

Device Problems Defective Alarm (1014); Failure to Deliver Shock/Stimulation (1133)

Patient Problem Unspecified Heart Problem (4454)

Event Type  Injury  

Event Description

Clinic manager ( (b)(6) ) reported a patient had a cardiac event with a zoll lifevest wearable defibrillator in which the product provided no audible alarm nor shock.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LIFEVEST
• Type of Device: WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): ZOLL
• MDR Report Key: 17524570
• MDR Text Key: 321138959
• Report Number: MW5131516
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1