BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI-MEASUREMENT MODULE X3

    MDR report key: 21872166 · Received April 21, 2025

    Report

    Report Number
    21872166
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    April 16, 2025
    Report Date
    April 17, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838082588
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    YOUNG PATIENT KEEPS REMOVING OXYGEN AND PULSE OXIMETERS. PATIENT REMOVED PULSE OXIMETER (OX), AND NO ALARM GENERATED TO NOTIFY CLINICIANS THAT PULSE OX HAD BEEN REMOVED. IN FURTHER REVIEWING, THE READING WAS NOT PICKED UP FOR ABOUT 30 MINUTES BEFORE IT WAS REALIZED. THIS FUNCTIONALITY IS WORKING AS INTENDED BY PHILIPS, WITH THE CYAN INOPERATIVE MESSAGE NOT PAGING OUT AS A HIGHER-LEVEL ALARM. HOWEVER THIS FUNCTIONALITY IS INADEQUATE FOR CLINICIAN NOTIFICATION AT THIS FACILITY, AND THE FACILITY IS REQUESTING ENHANCED FUNCTIONALITY TO INCLUDE CONFIGURABILITY OF THESE ALARMS UP TO A 'RED-LEVEL' ALARM THAT CAN APPROPRIATELY PAGE OUT AND NOTIFY CLINICIANS OUTSIDE THE PATIENT ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238892 INTELLIVUE MULTI-MEASUREMENT MODULE X3 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH INTELLIVUE X3 00884838082588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown