BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDE

    MDR report key: 422353 · Received October 11, 2002

    Report

    Report Number
    MW1026435
    Event Type
    Malfunction
    Date Received
    October 11, 2002
    Date of Event
    October 7, 2002
    Report Date
    October 11, 2002
    Manufacturer
    MDE
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TELEMETRY MONITOR SCREEN WENT BLANK FOR ABOUT 20 MINS. NOTIFIED BIOMED WHO TALKED MONITOR NURSE THROUGH SHUTTING DOWN THE SYSTEM AND RECALIBRATION. THE MONITOR NURSE NOTIFIED ALL FLOORS OF TELEMETRY DOWN TIME. NO ADVERSE OUTCOMES FOR PTS ON TELEMETRY DURING THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MDE TELEMETRY SYSTEM DRG MDE 20500-16 P/N366000-0096

    Patients

    Seq Age Sex Outcome Treatment
    1 *