BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP5, INTELLIVUE

    MDR report key: 1870154 · Received October 5, 2010

    Report

    Report Number
    1870154
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 30, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    THERE HAVE BEEN TOUCH SCREEN FAILURES IN FIVE (5) MP5 MONITORS WITHIN A THREE MONTH PERIOD AND TWO TEMPERATURE PRINTED CIRCUIT BOARD FAILURES. THESE MONITORS ARE ONLY A YEAR OLD. PHILIPS SELLS US THE PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP5, INTELLIVUE MONITOR, PHYSIOLOGICAL MHX PHILIPS MEDICAL SYSTEMS MP5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *