BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6031339 · Received October 14, 2016

    Report

    Report Number
    3008642652-2016-07563
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 14, 2016
    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 · 1

    DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGE UNABLE TO CHARGE BATTERY PACK) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS UNABLE TO RECHARGE A BATTERY PACK. THE CAUSE FOR THE FAILURE WAS CONTAMINATION ON THE BATTERY PCA. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNKNOWN LIQUID. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED BATTERY CHARGER/MODEM SN (B)(4) AND REPORTED THAT THE BATTERY CHARGER/MODEM WAS UNABLE TO CHARGE A BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682224 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1