BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2844850 · Received November 2, 2012

    Report

    Report Number
    3008642652-2012-02858
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    September 13, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ZOLL LIFECOR CORP
    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 (DAMAGED ELECTRODE BELT CONNECTOR) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR'S ELECTRODE BELT CONNECTOR WAS BROKEN FREE FROM THE MONITOR CASE AND SEVERAL WIRES IN THE CONNECTOR WERE DAMAGED. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR 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 BROKEN WIRES. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE ELECTRODE BELT CONNECTOR ON HIS MONITOR WAS DAMAGED. 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 CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR