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

Device Problem Defective Device (2588)

Patient Problems Bruise/Contusion (1754); Emotional Changes (1831); Fall (1848); Pain (1994); Injury (2348)

Event Date 12/08/2016

Event Type  Injury  

Event Description

Caller called to report that in (b)(6) 2016, he was wearing his lifevest to a 8:00 am cardio appt and everything was "all good" at that appt.He then proceeded to his next appt with cardio rehab via driving.Once he parked and got out of the car "and all of a sudden it felt like i was hit in the head.The device exploded and i was knocked to the ground".Reporter had bruises on his abdomen, pain and states feeling traumatized by the incident.This malfunction has been reported to zoll by the reporter and zoll has since exchanged the device for a new one.Reporter states that zoll has sent him bills for the device, has not informed him why his device malfunctioned and wonders where his old device is.Zoll contacted the reporter again in 2019 to inform him that his info has been hacked in a data breach.Reporter states that he has to file a motion with the courts by april 2020 and that he may have to include the fda to his motion since the device is fda approved.

• Brand Name: LIFEVEST
• Type of Device: WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORP.
• MDR Report Key: 9818108
• MDR Text Key: 183287253
• Report Number: MW5093659
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 73