BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER FLEX CARDIO MEDICAL EQUIPMENT

    MDR report key: 25111333 · Received May 7, 2026

    Report

    Report Number
    1051786-2026-100030
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 7, 2026
    Manufacturer
    INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS
    Product Code
    MWI
    PMA / PMN Number
    K101571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. D4: PRODUCT UDI - THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016, THEREFORE NO UDI. E1: REPORTING INSTITUTION PHONE #: (B)(6). REPORTER PHONE #: (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON XPER FLEX CARDIO MEDICAL EQUIPMENT INDICATING THAT THE FRACTIONAL FLOW RESERVE (FFR) MEASUREMENT SYSTEM INTEGRATED INTO THE XPERIM FLEX CARDIO OFTEN FREEZES, INTERRUPTING PATIENT MONITORING DURING THE PROCEDURE. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347620 XPER FLEX CARDIO MEDICAL EQUIPMENT MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO MEDICAL EQUIPMENT

    Patients

    Seq Age Sex Outcome Treatment
    1