BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFEVEST WCD 3000 SYSTEM

    MDR report key: 1012864 · Received March 12, 2008

    Report

    Report Number
    3002158293-2008-00105
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 27, 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 OF MONITOR SN 05001834 HAS BEEN COMPLETED. THE MONITOR WAS FOUND TO HAVE A REAR RESPONSE BUTTON SWITCH 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 BUTTON WAS REPAIRED AND THE MONITOR WAS RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE FAULTY RESPONSE BUTTON.

    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 A FRONT RESPONSE BUTTON 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 LEFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA