BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2920614 · Received December 7, 2012

    Report

    Report Number
    3008642652-2012-03214
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 8, 2012
    Report Date
    December 4, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ABNORMAL SHUTDOWN) HAS BEEN CONFIRMED. UPON EVALUATION, 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 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

    ZOLL CUSTOMER SUPPORT CONTACTED A (B)(6) MALE TO EXCHANGE HIS MONITOR. THE PT'S DOWNLOAD REVEALED THREE ABNORMAL SHUTDOWNS. 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 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR