BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1061095 · Received June 13, 2008

    Report

    Report Number
    3002158293-2008-00264
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 12, 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 PACK NOT POWERING UP WAS DUE TO A BLOWN FUSE. THE CELLS WERE ALSO DEFECTIVE. THE BATTERY PACK WAS REPAIRED, RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE BLOWN FUSE CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY RANDOM COMPONENT FAILURE. THE CAUSE OF THE DEFECTIVE CELLS WAS DUE TO THE FUSE BEING BLOWN AND NOT ALLOWING THE BATTERY TO CHARGE AND DISCHARGE PROPERLY. NO ADVERSE EVENT RESULTED FROM THE DAMAGED 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 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA