BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT MONITOR DISPLAY

    MDR report key: 1870450 · Received October 6, 2010

    Report

    Report Number
    9610816-2010-00557
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Report Date
    September 14, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K001664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A MONITOR MAY HAVE FALLEN DOWN. NO PT HARM WAS REPORTED. THE DISPLAY WAS OBVIOUSLY FAILING SHOWING ONLY BLACK LINES ON A WHITE BACKGROUND. WHILE THE DISPLAY FAILURE WAS OBVIOUS AND NOT A HEALTH RISK, AN UNEXPECTED FALL OF A MONITOR MAY BE A HEALTH RISK. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONITOR MAY HAVE FALLEN DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT MONITOR DISPLAY MHX,DRT MHX PHILIPS MEDICAL SYSTEMS M3046A

    Patients

    Seq Age Sex Outcome Treatment
    1