BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS INVIVO EXPRESSION MR UNIT

    MDR report key: 22338397 · Received June 25, 2025

    Report

    Report Number
    MW5171949
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 4, 2025
    Report Date
    June 16, 2025
    Manufacturer
    PHILIPS/INVIVO CORPORATION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE MRI COMPATIBLE EQUIPMENT FAILED TO FUNCTION WHILE IN USE IN 3-TESLA ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940177 PHILIPS INVIVO EXPRESSION MR UNIT MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS/INVIVO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other