BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIMA IGS 320

    MDR report key: 21295903 · Received February 3, 2025

    Report

    Report Number
    9613445-2025-00002
    Event Type
    Death
    Date Received
    February 3, 2025
    Date of Event
    January 4, 2025
    Report Date
    May 7, 2025
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    JAA
    PMA / PMN Number
    K122457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE HAS COMPLETED ITS INVESTIGATION. ANALYSIS OF SYSTEM LOGS AND SERVICE RECORDS CONFIRMED THAT THE SYSTEM OPERATES ACCORDING TO SPECIFICATIONS. THE X-RAY LOSS WAS ATTRIBUTED TO INADEQUATE ENVIRONMENTAL CONTROL, WITH ROOM TEMPERATURES FREQUENTLY OUT OF RANGE SINCE SEPTEMBER 2021. THE ROOM TEMPERATURE CONTROLS ARE SPECIFIED IN THE GE HEALTHCARE PRE-INSTALLATION MANUAL. THE PATIENT'S DEATH WAS DETERMINED TO BE AN ISOLATED INCIDENT CAUSED BY INADEQUATE ENVIRONMENTAL CONTROL, AND THE DEVICE DID NOT CONTRIBUTE TO THE EVENT. THE INVESTIGATION IS CLOSED AND ACTION HAS BEEN TAKEN BY THE CUSTOMER TO REPLACE THE A/C MODULE WITHIN THE TECHNICAL ROOM. POST-REPLACEMENT SYSTEM LOGS HAVE BEEN REVIEWED AND ARE WITHIN ACCEPTABLE PARAMETERS. NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE.

    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 BEIJING, 100176. D4: UDI NOT REQUIRED AS DEVICE IS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE. DEVICE INSTALLATION DATE IS 29-FEB-2016. 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

    THE CUSTOMER REPORTED THAT DURING AN EMERGENT VASCULAR PROCEDURE, THE GE HEALTHCARE SYSTEM DISPLAYED A COOLING FAILURE OF THE CHILLER AND X-RAY BECAME UNAVAILABLE A FEW MINUTES LATER. THE PROCEDURE COULD NOT BE COMPLETED AND THE PATIENT EXPIRED LATER THE SAME DAY. GE HEALTHCARE INVESTIGATION HAS BEEN OPENED AND IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179485 OPTIMA IGS 320 GE OPTIMA ANGIOGRAPHIC JAA GE HANGWEI MEDICAL SYSTEMS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Death