BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1250030 · Received November 14, 2008

    Report

    Report Number
    3002158293-2008-00596
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 16, 2008
    Report Date
    November 14, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL BATTERY PACK (B) (4) HAS BEEN COMPLETED. BATTERY PACK (B) (4) HAD DEFECTIVE CELLS. 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 PT TO USE THIS BATTERY PACK. THIS MEANT THAT THE BATTERY PACK WAS USED FOR GREATER THAN TWENTY-FOUR HOURS. THIS MEANS THAT THE PT 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 LAST PT TO USE THIS BATTERY PACK DID NOT REPORT ANY PROBLEMS. NO ADVERSE EVENT OCCURRED DUE TO THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    THE NURSE OF A (B) (6) FEMALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT ONE OF THE PT'S BATTERY PACKS WILL NOT CHARGE. THE NURSE STATED THAT THE BATTERY CHARGER DISPLAYS THE SOLID ORANGE CHARGING LIGHT AND THE RED FLASHING BAD BATTERY ICON. SUPPORT SENT THE PT 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 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR