BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE

    MDR report key: 1960054 · Received December 8, 2010

    Report

    Report Number
    1960054
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 16, 2010
    Report Date
    December 8, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE SCREEN ON THE PHILIPS INTELLIVUE MP90 WENT BLANK. THE MONITOR WAS REMOVED FROM THE OR AND A SPARE WAS USED TO REPLACE IT. MEDICAL ENGINEERING WAS UNABLE TO DUPLICATE THE PROBLEM, AND PUT THE MONITOR BACK INTO SERVICE. THE MONITOR AGAIN WENT BLANK AND IT WAS AGAIN REMOVED FROM SERVICE. PHILIPS WAS CALLED, AND THE REPRESENTATIVE REPLACED ONE BOARD IN THE CPU (THE BOARDS HAD BEEN REPLACED IN SEPTEMBER). THE MONITOR WAS ALLOWED TO RUN FOR SEVERAL DAYS, AND THEN BEGAN OPERATE INCORRECTLY AGAIN. THE MONITOR WAS RETURNED TO PHILIPS FOR INVESTIGATION. BACK IN SEPTEMBER THE BOARDS IN THE CPU ON THIS UNIT HAD BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MONITOR, PHYSIOLOGICAL MHX PHILIPS MEDICAL SYSTEMS MP90 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *