BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2232982 · Received July 20, 2011

    Report

    Report Number
    3008642652-2011-00267
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTONS FAILURE) HAS BEEN CONFIRMED. UPON EVALUATION BOTH RESPONSE BUTTONS WERE DAMAGED. THE TACTILE DOMES WERE SHORTED PREVENTING THE RESPONSE BUTTONS FORM FUNCTIONING. THE CAUSE FOR THE SHORTED TACTILE DOMES CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE SHORTED TACTILE DOMES. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THIS RESPONSE BUTTONS WERE NOT WORKING. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR