BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP50 INTELLIVUE PATIENT MONITOR

    MDR report key: 2123564 · Received June 9, 2011

    Report

    Report Number
    9610816-2011-00321
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Report Date
    May 19, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE REPORTED DESCRIPTION OF THIS COMPLAINT NOTES THERE WAS A PT MONITOR SPEAKER MALFUNCTION WITH NO AUDIO AVAILABLE. A VISUAL MESSAGE "SPEAKER MALFUNCTION" IS AVAILABLE ON THE MONITOR'S DISPLAY SCREEN SHOULD A SPEAKER MALFUNCTION BE DETECTED. ACCORDING TO THE INSTRUCTIONS FOR USE MANUAL SHOULD A SPEAKER MALFUNCTION BE DISPLAYED, IT IS SUGGESTED THAT YOU CONTACT YOUR SERVICE PERSONNEL TO CHECK THE SPEAKER AND CONNECTION TO THE SPEAKER. IT WAS NOTED THAT ALTHOUGH THE "NO AUDIO" WAS AVAILABLE FROM THE BEDSIDE MONITOR'S SPEAKERS, THE CUSTOMER'S BIOMEDICAL ENGINEER FOUND THAT SOME FAINT AUDIO WAS EMITTED FROM THESE SPEAKERS. THE BEDSIDE MONITOR'S MAIN BOARD WAS REMOVED AND REPLACED WITH AN ALTERNATIVE MAINBOARD. THE PT MONITOR WAS THEN TESTED AND PASSED THE PERFORMANCE VERIFICATION TESTS PRIOR TO RETURN INTO SERVICE FOR CUSTOMER USE. THERE HAVE BEEN NO FURTHER REPORTS OF SPEAKER MALFUNCTION SINCE REPLACEMENT OF THE PT'S MONITOR'S MAIN BOARD ASSOCIATED WITH THIS EVENT. DEVICE LABELING (IFU) ADEQUATELY WARNS USERS NOT TO RELY SOLELY ON AUDIBLE ALARMING. CONSIDERATION OF THIS COMPLAINT AND SIMILAR COMPLAINTS SUPPORTS THAT THERE ARE NO DESIGN MFG, MATERIALS, OR LABELING PROBLEMS. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THERE WAS AN INAUDIBLE ALARM ON THE MONITOR. NO PT 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