BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2890866 · Received November 21, 2012

    Report

    Report Number
    3008642652-2012-03070
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 27, 2012
    Report Date
    November 19, 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 SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT LIGHT UP) HAS BEEN CONFIRMED. UPON EVALUATION, THE POWER BRICK WAS DEFECTIVE. THE CAUSE OF THE DEFECTIVE POWER BRICK IS A DAMAGED CONNECTOR. THE CONNECTOR PINS WERE RECESSED INTO THE CONNECTOR. THE ROOT CAUSE OF THE RECESSED PINS CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED POWER BRICK CONNECTOR. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE CHARGER/MODEM WOULD NOT LIGHT UP. THE PT RECEIVED A REPLACEMENT 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 70 YR