BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 12795270 · Received November 11, 2021

    Report

    Report Number
    3008642652-2021-09953
    Event Type
    Injury
    Date Received
    November 11, 2021
    Date of Event
    October 26, 2021
    Report Date
    November 11, 2021
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005029
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION OF BATTERY CHARGER HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETS) WAS CONFIRMED.  UPON INVESTIGATION THE CHARGER WAS RESETTING AND UNABLE TO CHARGE A BATTERY PACK. THE CHARGER EXHIBITED A FAILURE AT PLD COMPONENT U1003 AND PXA COMPONENT U104 ON THE C/A BOARD.    THE ROOT CAUSE FOR THE U1003 AND U104 FAILURE COULD NOT BE POSITIVELY IDENTIFIED.   THERE WAS NO DEATH OR ADVERSE EVENT ASSOCIATED WITH THE CHARGER MALFUNCTION.

    Description of Event or Problem · 0

    A US DISTRIBUTOR REPORTED THAT A BATTERY CHARGER WAS RESETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698423 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005029

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown