BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4252885 · Received September 4, 2014

    Report

    Report Number
    3008642652-2014-02710
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 5, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL OF BATTERY CHARGER/MODEM SN (B)(4)HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO CHARGE BATTERIES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER / MODEM WAS UNABLE TO RECOGNIZE A BATTERY. THE CAUSE FOR THE RESETS WAS ISOLATED TO A CONTAMINATED BATTERY BOARD. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNK LIQUID. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539734 LIFEVEST WCD 4000 SYSTEM MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA