BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2911260 · Received December 14, 2012

    Report

    Report Number
    3008642652-2012-03284
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTONS NOT WORKING PROPERLY) HAS BEEN CONFIRMED. UPON EVAL, THE TOUCHSCREEN ASSEMBLY WAS DEFECTIVE, AFFECTING THE FUNCTIONALITY OF THE FRONT RESPONSE BUTTON. THE CAUSE FOR THE NON-FUNCTIONAL RESPONSE BUTTON IS THE DEFECTIVE SUBASSEMBLY. THE ROOT CAUSE FOR THE DEFECTIVE SUBASSEMBLY CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE SUBASSEMBLY. THE PT WAS ISSUE DA REPLACEMENT MONITOR.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR