BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2904583 · Received November 30, 2012

    Report

    Report Number
    3008642652-2012-03181
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    July 16, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) HAS BEEN CONFIRMED. UPON INVESTIGATION CONTAMINATION WAS FOUND ON THE CHARGER'S BATTERY BOARD, WHICH PREVENTED THE BATTERY CHARGER/MODEM FROM RECOGNIZING INSERTED BATTERY PACKS. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNKNOWN LIQUID. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED BATTERY BOARD. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER WAS DISPLAYING "BATTERY CHARGER PROBLEM." THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR