BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE PATIENT MONITOR

    MDR report key: 16379370 · Received February 14, 2023

    Report

    Report Number
    MW5114938
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    January 9, 2023
    Report Date
    February 9, 2023
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BLOOD PRESSURE DROPPED, NO BLOOD PRESSURE MONITOR ALARMS SOUNDED OR ALARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608526 INTELLIVUE PATIENT MONITOR MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH MX800865240

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female