BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1003252 · Received February 21, 2008

    Report

    Report Number
    3002158293-2008-00072
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 20, 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 MONITOR HAS BEEN COMPLETED. THE MONITOR WAS FOUND TO HAVE BOTH RESPONSE BUTTON SWITCHES THAT WOULD STICK INTERMITTENTLY. THE ROOT CAUSE OF THE RESPONSE BUTTON FAILURE IS THE METAL DOME STAYING IN THE COLLAPSED CONVEX SHAPE RATHER THAN RETURNING TO ITS NORMAL CONCAVE SHAPE. THE CAUSE OF THE COLLAPSED DOME WAS DETERMINED TO BE DELAMINATION OF THE SPACER LAYER WITHIN THE SWITCH. THE RESPONSE BUTTONS WERE REPAIRED AND THE MONITOR WAS RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE FAULTY RESPONSE BUTTONS.

    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 MONITOR HAD BOTH RESPONSE BUTTONS THAT WOULD STICK. 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 DIFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA