BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST

    MDR report key: 9818108 · Received March 10, 2020

    Report

    Report Number
    MW5093659
    Event Type
    Injury
    Date Received
    March 10, 2020
    Date of Event
    December 8, 2016
    Report Date
    March 10, 2020
    Manufacturer
    ZOLL MANUFACTURING CORP.
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277519 LIFEVEST WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MKJ ZOLL MANUFACTURING CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention