BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1082863 · Received July 25, 2008

    Report

    Report Number
    3002158293-2008-00338
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 24, 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 BATTERY PACK SN 71006943 HAS BEEN COMPLETED. THE BATTERY PACK HAD A DAMAGED BATTERY CONNECTOR. THE ROOT CAUSE OF THE DAMAGE CANNOT BE POSITIVELY IDENTIFIED BUT APPEARS TO BE THE RESULT OF THE BATTERY PACK BEING FORCED INTO A MISALIGNED MONITOR CONNECTOR. THE CONNECTOR WAS REPAIRED. THE BATTERY PACK WAS RETESTED ADN THEN RESTOCKED. THE DAMAGED CONNECTOR ON THE BATTERY PACK WAS REPLACED. NO ADVERSE EVENTS RESULTED FROM THE DAMAGED BATTERY PACK.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING OF BATTERY PACK WHICH WAS RETURNED FOR ROUTINE MAINTENANCE, IT WAS DISCOVERED THAT THE BATTERY PACK HAD A DAMAGED CONNECTOR. THE LAST PATIENT TO USE THIS BATTERY PACK DID NOT REPORT ANY PROBLEMS WITH IT.

    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 NA