BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2843825 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02826
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 23, 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 (CHECK THERAPY ELECTRODE MESSAGES, DAMAGED CONNECTOR) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR'S ELECTRODE BELTS CONNECTOR WAS BROKEN FREE FROM THE MONITOR CASE, AND THE BLACK PULSE WIRE INSIDE THE CONNECTOR WAS SEVERED. THE SEVERED PULSE WIRE CAUSED THE CHECK THERAPY ELECTRODE MESSAGES. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR AND BROKEN WIRE COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM THE MONITOR BEING DROPPED WHILE CONNECTED TO AN ELECTRODE BELT. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR AND WIRE. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS RECEIVING CHECK THERAPY ELECTRODE MESSAGES. A ZOLL PATIENT SERVICE REPRESENTATIVE LATER CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE ELECTRODE BELT CONNECTOR ON THE PATIENT'S MONITOR WAS BROKEN. 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 57 YR