BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3830435 · Received May 14, 2014

    Report

    Report Number
    3008642652-2014-01458
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 ALARMS) WAS CONFIRMED. UPON INVESTIGATION, THE MONITOR WAS NOT ABLE TO PROPERLY COMMUNICATE WITH AN ELECTRODE BELT. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN OPEN C609 CAPACITOR ON THE MONITOR C/A BOARD. THE ROOT CAUSE FOR THE OPEN CAPACITOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE OPEN CAPACITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS RECEIVING FREQUENT CHECK THERAPY ELECTRODE ALARMS. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287900 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR