BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1012866 · Received March 12, 2008

    Report

    Report Number
    3002158293-2008-00109
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 21, 2008
    Report Date
    March 11, 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 MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE MONITOR HAD AN OVER VOLTAGE CONDITION AND "DISCHARGE PROFILE FAULT" FLAGS BECAUSE THE CONNECTORS ON BOTH THE CA AND DEFIBRILLATOR BOARD HAD EXTENSIVE CONTAMINATION. BOTH THE BATTERY PACK CONNECTOR AND THE MODEM CONNECTOR WERE HEAVILY CORRODED. THE ROOT CAUSE OF THE DEFECTIVE COMPONENTS LOOKED TO BE WATER DAMAGE. THE MONITOR WAS REPAIRED, RETESTED AND RESTOCKED. NO ADVERSE EVENT OCCURRED DUE TO THE DEFECTIVE MONITOR. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY PROBLEMS.

    Description of Event or Problem · 1

    A REVIEW OF SVC DATA DETECTED A REPORTABLE EVENT. DURING SERVICING OF MONITOR WHICH WAS RETURNED FOR ROUTINE MAINTENANCE, IT WAS DISCOVERED THAT THE MONITOR WOULD NOT TREAT BECAUSE THE OVER VOLTAGE CONDITION WAS TRIGGERED AND THE DOWNLOAD REVEALED "DISCHARGE PROFILE FAULT" FLAGS. THE LAST PT TO USE THIS MONITOR 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