BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILIPS MONITOR R-061322 INTELLIVUE X3

    MDR report key: 18797037 · Received February 26, 2024

    Report

    Report Number
    MW5152037
    Event Type
    Other
    Date Received
    February 26, 2024
    Date of Event
    November 27, 2023
    Report Date
    February 15, 2024
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RE: PHILLIPS MONITOR R-061322, INTELLIVUE X-3, SERIAL NUMBER (B)(6), MX 750, SERIAL NUMBER (B)(6). THE MONITOR PERMITS THE USER TO INDEFINITELY SILENCE SAFETY ALARMS SO WHEN MONITOR DEFECTS AN ABNORMAL VALUE, THE VALUE SHOWS ON THE MONITOR, BUT THE MONITOR DOES NOT AUDIBLY ALARM TO ALERT THE CLINICAL TEAM. THIS IS A SIGNIFICANT PATIENT SAFETY CONCERN. ACCORDING TO THE MANUFACTURER, THIS FEATURE CANNOT BE MODIFIED, IT IS ALL OR NOTHING--EITHER YOU HAVE AUDIBLE ALARMS ALWAYS OR YOU HAVE NO AUDIBLE ALARMS. IDEALLY, THE AUDIBLE ALARM WOULD BE ABLE TO BE SILENCED FOR A SHORT TIMEFRAME WHEN CLINICALLY APPROPRIATE, BUT NOT INDEFINITELY. THIS FEEDBACK WAS COMMUNICATED TO THE COMPANY REPRESENTATIVE IN DEC 2023. REFERENCE REPORT: MW5152038.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496706 PHILIPS MONITOR R-061322 INTELLIVUE X3 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS NORTH AMERICA LLC INTELLIVUE X3

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other