BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE INFORMATION CENTER IX PIIC-IX

    MDR report key: 2929894 · Received January 22, 2013

    Report

    Report Number
    2929894
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 22, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    PIIC-IX IS A NEWLY MARKETED MONITORING SYSTEM FROM PHILIPS HEALTHCARE. SINCE THE INSTALL APPROXIMATELY 30 DAYS AGO, OUR SYSTEM WHICH COVERS ABOUT 150 TELEMETRY PATIENTS HAS HAD A SERIES OF OPERATIONAL PROBLEMS. PROBLEMS INCLUDE: MISSING VITAL SIGNS FROM SCREEN, LOCK UP OF SCREEN, SPONTANEOUS ACTIVATION OF FEATURES SUCH AS ALARM SILENCE, SPONTANEOUS DISPLAY OF MS WINDOWS SCREEN, SPONTANEOUS LOCK UP OF SYSTEM, SPONTANEOUS REBOOT OF SYSTEM. ALL OF THESE ISSUES HAMPER THE ABILITY OF STAFF TO MONITOR THE PATIENTS. NO PATIENT HARM.COMPLICATING THE PROBLEM IS A LACK OF PIIC-IX TRAINED SUPPORT STAFF READILY AVAILABLE WITHIN PHILIPS HEALTHCARE. RESPONSE TO TECH SUPPORT CALLS MAY TAKE UP TO 7 HOURS TO BE RETURNED. ONSITE RESPONSE TAKES DAYS TO GET 'TRAINED STAFF' IN. EVEN WHEN 'TRAINED STAFF' ARRIVE, THEY STILL ARE AT A LOSS FOR REASONS FOR THE PROBLEMS ARE NEED TO CONSTANTLY ESCALATE TO PHILIPS ENGINEERING. SOLUTIONS TO PROBLEMS ARE NOT READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29758 INTELLIVUE INFORMATION CENTER IX PIIC-IX SYSTEM, MONITOR, CARDIAC MHX PHILIPS MEDICAL SYSTEMS, INC PIIC-IX *

    Patients

    Seq Age Sex Outcome Treatment
    1 *