BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP50 INTELLIVUE PATIENT MONITOR

    MDR report key: 2132445 · Received June 14, 2011

    Report

    Report Number
    9610816-2011-00330
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Report Date
    May 23, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE REPORTED DESCRIPTION OF THIS COMPLAINT NOTES THERE WAS A "SPEAKER MALFUNCTION" VISUAL MESSAGE ON THE MONITOR'S DISPLAY SCREEN. THE CUSTOMER REPORTED RECEIVING BOTH AUDIBLE AND VISUAL ALARMS AT THE CENTRAL STATION MONITOR. NO PATIENT HARM WAS REPORTED. WE WILL CONSIDER THAT THERE WAS A LOSS OF AUDIO AT THE BEDSIDE MONITOR. 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 REPORTED DESCRIPTION OF THIS COMPLAINT NOTES THERE WAS A "SPEAKER MALFUNCTION" VISUAL MESSAGE ON THE MONITOR'S DISPLAY SCREEN. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP50 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8004A

    Patients

    Seq Age Sex Outcome Treatment
    1