BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS HEALTHCARE INTELLIVUE X3 (867030)

    MDR report key: 20514767 · Received October 22, 2024

    Report

    Report Number
    MW5161473
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    August 30, 2024
    Report Date
    October 16, 2024
    Manufacturer
    PHILIPS HEALTHCARE / PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALARMS NOT OCCURRING ON PHILIPS PATIENT MONITORS MX550 AND X3 DUE TO HARD AND SOFT INOP'S. DEVICE TOGGLES BETWEEN POOR SIGNAL AND SEARCHING WHICH IS RESETTING DELAYS AND PREVENTING THE ALARMS FROM OCCURRING. SEARCHING WILL OVERRIDE A CLINICAL ALARM. SPECIFICALLY, BETWEEN MASIMO SPO2 AND PHILIPS HARDWARE. REFERENCE REPORT: MW5161474.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369734 PHILIPS HEALTHCARE INTELLIVUE X3 (867030) MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS HEALTHCARE / PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH X3 - 867030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention