BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE

    MDR report key: 20598310 · Received November 4, 2024

    Report

    Report Number
    20598310
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    July 22, 2024
    Report Date
    July 25, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EARLIER THIS YEAR, PHILIPS UPGRADED THE SOFTWARE ON ALL OF OUR PHILIPS SERVERS AND CENTRAL MONITORS TO REVISION 4.2.3. THEY ALSO UPGRADED THE SOFTWARE ON ALL OF OUR BEDSIDE MONITORS AND PORTABLE X3 MONITORS TO REVISION P.01.04. AFTER THESE UPGRADES WE STARTED GETTING BLUE NO DATA MONITOR ALARMS ON ALL OF OUR CENTRAL MONITORS THROUGHOUT THE HOSPITAL. THESE ALARMS COME AND GO RANDOMLY. THEY CAN BE CLEARED BY UNDOCKING AND RE-DOCKING THE X3, BUT THIS IS ONLY TEMPORARY. NO DATA MONITOR IS A LOW PRIORITY ALARM, BUT IT GENERATES AN AUDIBLE TONE AT THE CENTRAL MONITOR EVERY 5 MINUTES, WHICH LEADS TO ALARM FATIGUE. PHILIPS RAN A REPORT ON THE AMOUNT OF NO DATA MONITOR ALARMS GENERATED IN A 30 DAY PERIOD, AND IT WAS OVER 47,000. AT ANY GIVEN TIME EVERY CENTRAL MONITOR IN THE HOSPITAL HAS A NO DATA MONITOR ALARM DISPLAYING ON SEVERAL BEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774746 INTELLIVUE MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH PIC IX, MX400, MX500, MX800, MX850

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male