BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1121047 · Received August 14, 2008

    Report

    Report Number
    3002158293-2008-00368
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 10, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF THE BATTERY PACK HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE BATTERY PACK HAD A DAMAGED LOCKING TAB. THE BATTERY PACK WAS REPAIRED. IT WAS RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE DAMAGED CLIP CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY DUE TO FORCIBLE REMOVAL OF THE BATTERY PACK FROM THE MONITOR WITHOUT PRESSING THE LOCKING TAB BEFORE PULLING. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    THE RECENT DOWNLOAD FROM A FEMALE PATIENT REVEALED SEVERAL "BATTERY PACK FAULTS". THESE FLAGS OCCURRED WITH THE SAME BATTERY PACK. SUPPORT ATTEMPTED TO CONTACT THE PATIENT TO DISCUSS THE EXCHANGE OF THE BATTERY PACK. THE PATIENT'S MAIN NUMBER IS DISCONNECTED. SUPPORT LEFT A MESSAGE FOR THE PATIENT'S DAUGHTER. IN 2008, SUPPORT CONTACTED THE PATIENT'S DAUGHTER AGAIN TO DISCUSS THE EXCHANGE OF THE BATTERY PACK. SIX DAYS LATER, THE PATIENT CALLED LIFECOR TO GET A REPLACEMENT BATTERY PACK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR