BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIMA

    MDR report key: 24197429 · Received January 28, 2026

    Report

    Report Number
    9613445-2026-00002
    Event Type
    Death
    Date Received
    January 28, 2026
    Date of Event
    December 15, 2025
    Report Date
    January 28, 2026
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    OWB
    PMA / PMN Number
    K122457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS BEIJING - WEST AREA OF BUILDING NO.3, NO.1 YONGCHANG NORTH ROAD, BEIJING ECONOMIC AND TECHNOLOGICAL DEVELOPMENT AREA CHINA BEIJING, 100176, GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    DURING AN EMERGENCY CARDIAC EXAMINATION ON (B)(6) 2025 THE GE HEALTHCARE SYSTEM WAS UNABLE TO INITIATE X RAY IMAGING DUE TO A SUSPECTED X RAY TUBE FAILURE, DESPITE MULTIPLE RESET ATTEMPTS. THE EXAMINATION COULD NOT BE PERFORMED, AND THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY LOCATED ~20 KM AWAY, WHERE A PROCEDURE USING ANOTHER DEVICE WAS INITIATED. GE HEALTHCARE WAS INFORMED THAT THE PATIENT SUBSEQUENTLY DIED AT THE SECOND FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260908 OPTIMA INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE HANGWEI MEDICAL SYSTEMS CO., LTD. IGS 320 001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death