BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP20 INTELLIVUE PATIENT MONITOR

    MDR report key: 1865068 · Received October 5, 2010

    Report

    Report Number
    9610816-2010-00556
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Report Date
    August 20, 2010
    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 CUSTOMER REPORTED THAT A MONITOR FELL AND DAMAGED THE SCREEN. NO PATIENT HARM WAS REPORTED. THE AVAILABLE INFORMATION DOES NOT SUPPORT THAT THIS WAS A MALFUNCTION, BUT PHILIPS HAS NOT YET VERIFIED THAT THE MONITOR FALLING DOES NOT REPRESENT A HEALTH RISK. NOTE THAT THIS DEVICE HAS NO SEPARATE SCREEN - THE DISPLAY IS INTEGRAL TO THE MONITOR. WE ARE CONSIDERING THAT A USER DROPPED THE MONITOR (TRANSPORT MONITOR) AND DAMAGED THE SCREEN. 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 A MONITOR FELL AND DAMAGED THE SCREEN. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP20 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8001A

    Patients

    Seq Age Sex Outcome Treatment
    1