BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1121083 · Received August 14, 2008

    Report

    Report Number
    3002158293-2008-00365
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    May 15, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE FAULTS WAS DEFECTIVE BATTERY CELLS WITHIN THE BATTERY PACK. THE ROOT CAUSE OF THE DEFECTIVE CELLS IS NOT KNOWN, BUT WAS PROBABLY DUE TO EXCESSIVE DISCHARGING. MANY "BATTERY RUNTIME EXPIRED" FLAGS WERE SEEN ON THE FINAL DOWNLOAD FROM THE LAST PATIENT TO USE THIS BATTERY PACK. THIS MEANT THAT THE BATTERY PACK WAS USED FOR GREATER THAN TWENTY-FOUR HOURS. THIS MEANS THAT THE PATIENT CONTINUED TO USE A DEPLETED BATTERY FOR HOURS AFTER THE EXPIRED RUNTIME ALARMS SOUNDED. THE DEFECTIVE CELLS WERE REPLACED. THE BATTERY PACK WAS RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE FAULTY BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A FOREIGN DISTRIBUTOR SENT AN EMAIL CONTAINING A SERVICE REQUEST FOR A BATTERY PACK. RESEARCH REVEALED THE LAST PATIENT TO USE THIS BATTERY PACK WAS EXCESSIVELY DISCHARGING THE 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 UNK