BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2890867 · Received November 21, 2012

    Report

    Report Number
    3008642652-2012-03069
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 19, 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 (SERVICE CODE 204) HAS BEEN CONFIRMED UPON EVALUATION, THE BELT RECEPTACLE CONNECTOR WAS NOT PROPERLY SEATED IN THE J1001 CONNECTOR (BELT CONNECTOR) ON THE CA (COMPUTER/ANALOG) BOARD. THE CAUSE OF THE CODE 204 IS A DISRUPTION OF COMMUNICATION BETWEEN THE MONITOR AND ELECTRODE BELT. THE CAUSE OF THE DISRUPTION IN COMMUNICATION IS THE IMPROPERLY SEATED RECEPTACLE CONNECTOR. THE ROOT CAUSE OF THE RECEPTACLE CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE AT THE CONNECTOR WHILE THE ELECTRODE BELT WAS ATTACHED TO THE MONITOR. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR BELT CONNECTOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT A SERVICE CODE 204. THE ISSUE WAS INSULATED TO THE MONITOR. 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 61 YR