BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP40 INTELLIVUE PATIENT MONITOR

    MDR report key: 2062959 · Received March 16, 2011

    Report

    Report Number
    9610816-2011-00138
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    February 24, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 USER ALSO NOTES THAT THERE WAS NO ALARM SOUND FOR THE MONITOR'S SPEAKER. THE DEVICE DISPLAY PROVIDED A VISUAL DISPLAY ALERT OF A SPEAKER MALFUNCTION; THE DEVICE LABELING INSTRUCTS THAT EFFECTIVE MONITORING INCLUDES CLOSE PERSONAL OBSERVATION, AND WARNS AGAINST RELIANCE SOLELY ON AUDIBLE ALARMING. IN THE PRESENCE OF LIFE-THREATENING EVENTS WHEN NO SOUND IS AUDIBLE, SERIOUS INJURY AND/OR DEATH CAN OCCUR. ACCORDING TO THE SERVICE ENGINEER, THE MONITOR'S SPEAKER WAS REPLACED. THERE HAVE BEEN NO FURTHER SPEAKER MALFUNCTION ISSUES REPORTED WITH THIS CITED MONITOR. CONSIDERATION OF THIS COMPLAINT AND ANY SIMILAR COMPLAINT DOES NOT INDICATE ANY POSSIBLE DESIGN, MFG, MATERIALS, OR LABELING PROBLEM. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A "SPEAKER MALFUNCTION" VISUAL MESSAGE ON THE MONITOR'S DISPLAY SCREEN. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP40 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8003A

    Patients

    Seq Age Sex Outcome Treatment
    1