BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2033084 · Received February 28, 2011

    Report

    Report Number
    3002158293-2011-00227
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 25, 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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (MONITOR WON'T POWER UP) HAS BEEN CONFIRMED. UPON EVAL, THE MONITOR WAS FOUND TO HAVE DEBRIS ON A COMPONENT ON THE AUXILIARY BOARD. ONE OR MORE OF THE PADS ON COMPONENT J2005 WERE CONTAMINATED WHICH SHORTED OUT THE IN-SYSTEM PROGRAMMABLE (ISP) LINE. THIS CAUSED THE MONITOR TO BE STUCK IN ISP MODE AND PREVENTED THE SYSTEM FROM POWERING UP PROPERLY. THE ROOT CAUSE FOR THE CONTAMINATION CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATION. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WOULD NOT POWER ON. 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 CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR