BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3012937 · Received February 26, 2013

    Report

    Report Number
    3008642652-2013-00537
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 19, 2013
    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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK ELECTRODE BELT MESSAGES) WAS CONFIRMED. UPON INVESTIGATION TO MONITOR'S ELECTRODE BELT CONNECTOR WAS BROKEN FREE FROM THE MONITOR CASE AND THE CONNECTOR PULSE WIRE WAS BROKEN. 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 FORM THE DAMAGE MONITOR CONNECTOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE SPOUSE OF A (B)(6) PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT WAS RECEIVING CHECK ELECTRODE BELT MESSAGES. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83163 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR