BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2033463 · Received March 23, 2011

    Report

    Report Number
    3002158293-2011-00350
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    January 28, 2011
    Report Date
    March 22, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEMS (MEMORY FAILURE, CRC DATA ERROR FLAGS, SCREEN BLANK) HAVE BEEN CONFIRMED. UPON VISUAL INSPECTION, IT WAS FOUND THAT THE END CAP WAS SEPARATED FROM THE MONITOR CASE AND ALL THREE CABLES RUNNING FROM THE COMPUTER/ANALOG PCA BOARD TO THE AUXILIARY BOARD WERE UNPLUGGED. THE ROOT CAUSE FOR THE END CAP SEPARATION CANNOT BE POSITIVELY IDENTIFIED BUT WAS PROBABLY THE RESULT OF A DROP OR EXCESSIVE FORCE. DEVICE EVALUATION OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (MONITOR WON'T POWER UP) HAS BEEN CONFIRMED. UPON EVALUATION THE ELECTRODE BELT CABLE WAS FOUND TO HAVE A SMALL CUT. THE DAMAGE TO THE ELECTRODE BELT CAUSED A SHORT IN THE 5V LINE WHICH CAUSED THE MONITOR TO SHUTDOWN. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR AND ELECTRODE BELT CABLE. THE PATIENT RECEIVED A REPLACEMENT MONITOR AND ELECTRODE BELT. DEVICE MANUFACTURE DATE: MONITOR (B)(4), ELECTRODE BELT (B)(4): 02/2010.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WAS NOT WORKING PROPERLY. THE FRONT RESPONSE BUTTON WAS FLASHING RED AND THEN THE SCREEN WENT DARK. WHEN HE MANIPULATED THE ELECTRODE BELT CABLE AT THE CONNECTOR, THE MONITOR WOULD GO BACK TO NORMAL. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR AND ELECTRODE BELT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR