BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3221508 · Received July 2, 2013

    Report

    Report Number
    3008642652-2013-01750
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION, THE MONITOR WOULD NOT POWER ON PROPERLY. THE CAUSE WAS CORROSION TO COMPONENTS J101, J501 AND U201 ON THE COMPUTER/ANALOG BOARD AND THE TABLETOP BOARD. THE CAUSE FOR THE CORROSION WAS LIKELY CONTAMINATION. THE ROOT CAUSE FOR THE CONTAMINATION WAS UNABLE TO BE POSITIVELY DETERMINED, BUT WAS LIKELY LIQUID INGRESS OF AN UNKNOWN CONTAMINANT. NO ADVERSE EVENT RESULTED FROM THE CORROSION. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S MOTHER CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S MONITOR WOULD NOT POWER ON PROPERLY. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301737 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR