BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2882136 · Received November 12, 2012

    Report

    Report Number
    3008642652-2012-02950
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 10, 2012
    Report Date
    November 5, 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 OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (MONITOR OVERHEATING) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE MONITOR WAS DRAWING EXCESSIVE CURRENT. THERMAL DAMAGE WAS DISCOVERED ON RESISTORS R45 AND R684, TRANSISTOR Q701, AND PROGRAMMABLE LOGIC DEVICE U1003. THE CAUSE FOR THE THERMAL DAMAGE AND EXCESSIVE CURRENT WAS ISOLATED TO A DAMAGED HIGH-VOLTAGE CAPACITOR C22. THE NEGATIVE LEAD OF C22 WAS BROKEN FROM THE DEFIBRILLATOR BOARD. THE ROOT CAUSE FOR THE DETACHED C22 LEAD COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE WAS LIKELY CAUSED BY THE MONITOR IMPACTING A HARD SURFACE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED C22 CAPACITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A ZOLL TERRITORY MANAGER (TM) REPORTED TO ZOLL CUSTOMER SUPPORT THAT AN (B)(6) MALE PATIENT'S MONITOR WAS OVERHEATING. THE PATIENT 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 80 YR