BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP30 INTELLIVUE PATIENT MONITOR

    MDR report key: 1890764 · Received November 1, 2010

    Report

    Report Number
    9610816-2010-00563
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Report Date
    September 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THERE WAS A SPEAKER MALFUNCTION. AN INOP WAS SHOWN ON SCREEN, BUT PHILIPS HAS NOT YET DETERMINED IF AUDIO WAS FUNCTIONAL. NO PATIENT HARM WAS REPORTED. ATTEMPT AT REPAIR BY EXCHANGING THE MAIN BOARD WAS NOT SUCCESSFUL. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 THERE WAS A SPEAKER MALFUNCTION. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP30 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8002A

    Patients

    Seq Age Sex Outcome Treatment
    1