BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 15552285 · Received October 6, 2022

    Report

    Report Number
    3008642652-2022-24287
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    August 31, 2022
    Report Date
    October 6, 2022
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION OF BATTERY CHARGER HAS BEEN COMPLETED. THE REPORTED PROBLEM (DL 202 + 176) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER WAS UNABLE TO CHARGE/RECOGNIZE A BATTERY PACK. THE CAUSE FOR THE FAILURE WAS CONTAMINATION ON THE BATTERY BOARD PCA. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNKNOWN LIQUID. LIFEVEST PATIENT INSTRUCTIONS FOR USE REMIND AND WARN PATIENTS NOT TO EXPOSE THE LIFEVEST ELECTRONIC COMPONENTS TO LIQUIDS. THERE WAS NO ADVERSE EVENT THAT RESULTED FROM THE DAMAGED CHARGER.

    Description of Event or Problem · 0

    A US DISTRIBUTOR REPORTED THAT A BATTERY CHARGER WAS UNABLE TO CHARGE A BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2859741 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown