BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

    MDR report key: 9482058 · Received December 17, 2019

    Report

    Report Number
    1051786-2019-00061
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    December 5, 2019
    Report Date
    December 12, 2019
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K101571
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE INVESTIGATION FOR THE ISSUE REPORTED CONCLUDES NO MALFUNCTION OF THE FLEX CARDIO DEVICE OCCURRED. THE ATTENDING FIELD SERVICE ENGINEER CONFIRMED THIS COMPLAINT WAS ATTRIBUTED TO THE AZURION PRODUCT. NO FURTHER ACTION OR INVESTIGATION RELATED TO THE FLEX CARDIO DEVICE IS WARRANTED BASED ON THE AVAILABLE INFORMATION AT THE TIME OF COMPLAINT CLOSURE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    UNABLE TO CONFIRM SERIAL NUMBER. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THE PATIENT REPORTEDLY SURVIVED. AFTER A SYSTEM REBOOT, THE SYSTEM FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE ON A PATIENT, THE SCREEN LOST THE HEMO SIGNAL. WHILE THE HEART OF THE PATIENT STOPPED BEATING. THEY NOTICED THIS ASYSTOLE WITH A DELAY ON THEIR ARTERIAL PRESSURE LINE BECAUSE THEY NO LONGER HAD A HEMO SIGNAL PRESENT IN THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272404 XPER FLEX CARDIO PHYSIOMONITORING SYSTEM CARDIOVASCULAR MONITOR MWI INVIVO CORPORATION 860335 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1