BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3060519 · Received March 26, 2013

    Report

    Report Number
    3008642652-2013-00819
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY - DEVICE EVAL OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ABNORMAL SHUTDOWNS) HAS BEEN CONFIRMED. UPON EVAL, THERE WAS CONTAMINATION INSIDE THE MONITOR WHICH CORRODED THE J502 CONNECTOR AND THE JTAG BOARD. THE CAUSE OF THE ABNORMAL SHUTDOWNS IS THE DAMAGED J502 AND THE JTAG BOARD. THE CAUSE OF THE DAMAGE IS THE CORROSION. THE CAUSE OF THE CORROSION DAMAGE IS CONTAMINATION. THE ROOT CAUSE OF THE CONTAMINATION IS LIKELY LIQUID INGRESS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MAPLE PT'S NURSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S MONITOR WAS NOT FUNCTIONING PROPERLY AND DISPLAYED A SERVICE CODE. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124852 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR