BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1791145 · Received July 30, 2010

    Report

    Report Number
    3002158293-2010-00793
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    June 25, 2010
    Report Date
    July 30, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER FAULTS) HAS BEEN CONFIRMED. UPON RECEIPT, THE CHARGER WAS UNABLE TO COMPLETELY CHARGE A BATTERY. IT WAS DISCOVERED THAT ALL OF THE BOARDS IN THE CHARGER WERE DAMAGED BY CONTAMINATION AND WERE REPLACED. THE ROOT CAUSE OF THE CONTAMINATED CHARGER CANNOT BE POSITIVELY DETERMINED, BUT WAS LIKELY DUE TO LIQUID INGRESS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD FEMALE PT CALLED IN TO ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT SHE RECEIVED A MESSAGE ON THE CHARGER SAYING IT NEEDED TO BE REPLACED. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    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 40 YR