BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS INTELLIVUE MP70

    MDR report key: 680704 · Received February 8, 2006

    Report

    Report Number
    680704
    Event Type
    Malfunction
    Date Received
    February 8, 2006
    Date of Event
    February 1, 2006
    Report Date
    February 8, 2006
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US

    Narratives

    Description of Event or Problem · 1

    THERE IS A GLITCH IN THE SOFTWARE FOR THE PHILIPS MONITOR THAT COULD CONTRIBUTE TO PT INJURY. THE MONITOR WILL ALARM FOR ECG AND PULSE OXIMETRY. THE ALARM SETUP MENU FOR ECG HAS AN "ALARM" ON/OFF BUTTON. BELOW THE "ALARM" BUTTON IS AN "ALARM SOURCE" BUTTON THAT ALLOWS YOU TO TURN ON PULSE OX ALARM, WHICH TURNS OFF ECG ALARM. AT QUICK GLANCE, A NURSE SEES THAT SHE IS IN THE ECG MENU (TITLE BAR) AND ALSO SEES THAT THE "ALARM" BUTTON IS ON. WHAT SHE WOULDN'T REALIZE IS THAT IF "PULSE" IS LISTED BELOW THE "ON", ECG WILL NOT ALARM.THE SETUP MENU FOR "PULSE OX" HAS THE SAME "ALARM ON/OFF" BUTTON. HOWEVER, IT DOES NOT HAVE THE "ALARM SOURCE" BUTTON. THEREFORE, AT QUICK GLANCE A NURSE WILL SEE THE TITLE BAR "PULSE OX" AND "ALARM ON" AND KNOW THAT PULSE OX IS ON. THE ECG MENU SHOULD BE THE SAME. YOU SHOULD NOT BE ABLE TO TURN ON THE PULSE OX ALARM FROM THE ECG MENU.BIOMED DEPT CONTACTED PHILIPS A WEEK AGO. PHILIPS SAID THEY NEEDED TO DEVELOP A SOFTWARE FIX FOR THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS INTELLIVUE MP70 MONITOR MHX PHILIPS MEDICAL SYSTEMS, INC MP70 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *