BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3983758 · Received June 25, 2014

    Report

    Report Number
    3008642652-2014-01922
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER FAULT) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS UNABLE INVESTIGATION THE BATTERY CHARGER/MODEM WAS UNABLE TO CHARGE BATTERY PACKS. THE CAUSE FOR THE FAILURE WAS ISOLATED TO CONTAMINATION ON THE BATTERY PCA BOARD. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNK LIQUID. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    THE HUSBAND OF A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT SHE WAS RECEIVING BATTERY CHARGER FAULTS. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372190 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR