BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1172608 · Received September 19, 2008

    Report

    Report Number
    3002158293-2008-00473
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 9, 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 EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE BATTERY NOT CHARGING WAS DUE TO A BROKEN WHITE WIRE ON THE CELLS. THE WHITE WIRE IS THE ONE THAT CONNECTS THE BATTERY CELLS TO THE CONNECTOR. THE ROOT CAUSE OF THE BROKEN WIRE IS NOT KNOWN, BUT WAS PROBABLY AN ASSEMBLY ERROR. THE WHITE WIRE WAS PROBABLY NOT SOLDERED WITH ENOUGH SOLDER. ASSEMBLERS HAVE BEEN INSTRUCTED AND SHOWN HOW MUCH SOLDER TO BE PUT ON THIS WIRE. THE WIRE WAS 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.

    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 WOULD NOT CHARGE. THE LAST PT 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 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA