BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT MONITOR DISPLAY

    MDR report key: 1942280 · Received December 22, 2010

    Report

    Report Number
    9610816-2010-00839
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    November 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K001664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE WAS PROVIDING A FAULTY SPEAKER INOP MESSAGE. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO REGARDING THIS INCIDENT 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 DEVICE WAS PROVIDING A FAULTY SPEAKER INOP MESSAGE.

    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