BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP50 INTELLIVUE PATIENT MONITOR

    MDR report key: 2241670 · Received September 2, 2011

    Report

    Report Number
    9610816-2011-00515
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 26, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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" WAS DISPLAYED ON THE MONITOR'S SCREEN. RISK ANALYSIS - IN THE PRESENCE OF LIFE THREATENING EVENTS WHEN NO SOUND IS AVAILABLE FROM THE MONITOR, POSSIBLE SERIOUS INJURY AND/OR DEATH CAN OCCUR. HOWEVER, A VISUAL MESSAGE "SPEAKER MALFUNCTION" IS AVAILABLE IF 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 THE CONNECTION TO THE SPEAKER. ROOT CAUSE - A REPLACEMENT BEDSIDE MONITOR MAIN BOARD/SPEAKER ASSEMBLY BOARD WAS ORDERED AND INSTALLED TO RESOLVE THE PROBLEM. THE PT MONITOR WAS DELIVERED TO THE CUSTOMER IN 2004. RISK ANALYSIS - DEVICE LABELING (IFU) ADEQUATELY WARNS USERS NOT TO RELY SOLELY ON AUDIBLE ALARMING AND SPECIFIES THAT EFFECTIVE MONITORING INCLUDES CLOSE PERSONAL OBSERVATION. 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 REPORTED DESCRIPTION OF THIS COMPLAINT NOTES THERE WAS A PT MONITOR SPEAKER MALFUNCTION. IT WAS CONFIRMED THAT THERE WAS NO AUDIO SENT FROM THE MONITOR'S SPEAKER. 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