BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2871344 · Received September 28, 2012

    Report

    Report Number
    2871344
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 16, 2012
    Report Date
    September 28, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHILIPS MONITOR MODULE IN ONE OF THE PATIENT ROOMS STOPPED WORKING AND THE SCREEN WENT BLACK WITH NO WAVEFORMS. SCREEN SUDDENLY WENT BLACK FOR NO APPARENT REASON AND STAFF WAS UNABLE TO BRING BACK THE WAVEFORM WITHOUT REPLACING THE WHOLE MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MONITOR, PHYSIOLOGICAL MHX PHILIPS MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *