BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2220610 · Received July 15, 2011

    Report

    Report Number
    3008642652-2011-00228
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    May 22, 2011
    Report Date
    July 14, 2011
    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/MODEM (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER/MODEM SCREEN WILL NOT LIGHT UP) HAS BEEN CONFIRMED. UPON EVALUATION THE POWER BRICK CONNECTOR WAS BENT AND WOULD NOT STAY CONNECTED TO THE CHARGER, CAUSING THE CHARGER TO FAIL TO POWER UP. THE CAUSE FOR THE DAMAGED CONNECTOR CANNOT BE POSITIVELY DETERMINED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER BRICK CONNECTOR. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    THE SPOUSE OF A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE BATTERY CHARGER'S SCREEN WOULD NOT LIGHT UP. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR