BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3040444 · Received March 13, 2013

    Report

    Report Number
    3008642652-2013-00697
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 11, 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 EVAL SUMMARY - DEVICE EVAL OF BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (POWER BRICK CONNECTOR DAMAGED) WAS CONFIRMED. UPON EVAL, IT WAS DETERMINED THAT THE POWER UNIT CONNECTOR WOULD OT POWER UP THE CHARGER. THE ROOT CAUSE FOR THE FAULTY CONNECTION IS LIKELY DUE TO THE PINS IN THE CONNECTOR BEING RECESSED DUE TO A COMBINATION OF AN ASSEMBLY ERROR AND EXCESSIVE FORCE APPLIED DURING MATING. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CONNECTOR. THE PT RECEIVED A REPLACEMENT CHARGER.

    Description of Event or Problem · 1

    THE FIANCE OF A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S BATTERY CHARGER/MODEM POWER BRICK CONNECTOR WAS DAMAGED. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106150 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR