BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1172614 · Received September 19, 2008

    Report

    Report Number
    3002158293-2008-00458
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 18, 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 MFR DATE: BATTERY PACK - 12/2007; BATTERY PACK - 01/2008; BATTERY CHARGER - 12/2007. DEVICE EVAL SUMMARY: DEVICE EVAL OF BOTH BATTERY PACKS, AND BATTERY CHARGER HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE DEFECTIVE BATTERY CHARGER WAS A DEFECTIVE Q1 CHIP. THIS BAD CHIP CAUSED THE BATTERY PACK TO NOT ENTER CHARGING MODE. THE ROOT CAUSE OF THE DEFECTIVE Q1 CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY RANDOM COMPONENT FAILURE. THE FAULTY CHARGER WAS REPAIRED. IT WAS THEN RETESTED AND RESTOCKED. A BATTERY PACK 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. THE SECOND BATTERY PACK WAS FULLY FUNCTIONAL. IT WAS RESTESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BATTERY CHARGER AND BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER AND BATTERY PACKS.

    Description of Event or Problem · 1

    THE RECENT DOWNLOAD FROM A MALE PT REVEALED A COUPLE "BATTERY CHARGER FAULT" FLAGS. FURTHER REVIEW OF THE FLAGS REVEALED FURTHER "BATTERY CHARGER FAULT" AND A BATTERY PACK FAULT" FLAG. SUPPORT SENT THE PT REPLACEMENT BATTERY PACKS, AND A REPLACEMENT BATTERY CHARGER.

    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 76 YR