BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2251313 · Received August 12, 2011

    Report

    Report Number
    3008642652-2011-00440
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 11, 2011
    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 BUTTON NOT WORKING) HAS BEEN CONFIRMED. UPON INSPECTION, IT WAS FOUND THAT THE REAR RESPONSE BUTTON WAS NOT FUNCTIONAL. THIS WOULD NOT ALLOW THE MONITOR TO POWER ON PAST THE SPLASH SCREEN. THE REAR RESPONSE BUTTON CABLE WAS TORN CAUSING THE BUTTON TO BE INOPERATIVE. THE ROOT CAUSE OF THE TORN RESPONSE BUTTON CABLE CANNOT BE POSITIVELY DETERMINED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE INOPERATIVE RESPONSE BUTTON. 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 HIS RESPONSE BUTTONS WERE NOT RESPONDING WHEN HE PRESSED THEM. THE PT WAS PROVIDED WITH 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 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR