BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 17209458 · Received June 27, 2023

    Report

    Report Number
    3008642652-2023-06308
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    May 11, 2023
    Report Date
    June 27, 2023
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    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 WERE NO ADVERSE EVENTS ASSOCIATED WITH THE CHARGER MALFUNCTION.

    Description of Event or Problem · 0

    A US DISTRIBUTOR REPORTED A BATTERY CHARGER WAS RESETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833767 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown