BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2961430 · Received January 18, 2013

    Report

    Report Number
    3008642652-2013-00164
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    October 7, 2012
    Report Date
    January 15, 2013
    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 (DEFECTIVE CONNECTOR ON POWER BRICK) HAS BEEN CONFIRMED. UPON EVALUATION, THE POWER BRICK WAS DEFECTIVE. THE CAUSE OF THE DEFECTIVE POWER BRICK IS A DAMAGED CONNECTOR. THE ROOT CAUSE OF THE DAMAGED CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED POWER BRICK CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    WHILE VISITING A (B)(6) MALE PATIENT FOR AN UNRELATED ISSUE, A PATIENT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE POWER BRICK CONNECTOR ON THE PATIENT'S BATTERY CHARGER WAS DAMAGED. THE PATIENT WAS PROVIDED WITH A REPLACEMENT BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28418 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR