BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2983310 · Received February 4, 2013

    Report

    Report Number
    3008642652-2013-00284
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ZOLL LIFECOR CORP
    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 SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER FAULTS) HAS BEEN CONFIRMED. AS RECEIVED, THE CHARGER WOULD NOT CHARGER. UPON EVALUATION, THE POWER UNIT CONNECTOR WAS DAMAGED. THE CAUSE OF THE INABILITY TO CONNECT WITH THE CHARGER AND THE INABILITY TO CHARGE IS A DAMAGED POWER SUPPLY CONNECTOR. THE PINS IN THE POWER SUPPLY CONNECTOR WERE RECESSED. THE ROOT CAUSE OF THE RECESSED POWER SUPPLY CONNECTOR PINS CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FORM THE DEFECTIVE POWER SUPPLY CONNECTOR. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT'S SON'S FIANCE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THERE WAS A SHORT IN THE WIRING FOR THE BATTERY CHARGER POWER SUPPLY. THE PT WAS ISSUED A REPLACEMENT CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47479 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR