BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 4100

    MDR report key: 21832426 · Received April 14, 2025

    Report

    Report Number
    9611343-2025-00006
    Event Type
    Injury
    Date Received
    April 14, 2025
    Date of Event
    January 28, 2025
    Report Date
    June 13, 2025
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K042053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS BUC - 283 RUE DE LA MINIERE FRANCE BUC YVELINES, 78530. THE GE HEALTHCARE DEVICE HAS NO UDI SINCE IT WAS MANUFACTURED BEFORE UDI IMPLEMENTATION.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE HAS COMPLETED ITS INVESTIGATION. A REVIEW OF THE SYSTEM LOGS CONFIRMED THAT THE SYSTEM OPERATED WITHIN ITS SPECIFICATIONS. THE ADDITIONAL X-RAY DOSE WAS ATTRIBUTED TO THE OPERATOR DECISION. THE PATIENTÂS INJURY WAS DETERMINED TO BE AN ISOLATED CASE, RESULTING FROM A COMPLEX AND PROLONGED FLUOROSCOPIC PROCEDURE. FOR LARGER PATIENTS, SUCH PROCEDURES MAY LEAD TO SKIN INJURIES WHICH IS A KNOWN SIDE EFFECT. IT IS THE PHYSICIAN'S RESPONSIBILITY TO ASSESS THE BENEFITS VERSUS THE POTENTIAL RISKS FOR EACH PATIENT. THE INVESTIGATION IS NOW CLOSED, AND NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE.

    Description of Event or Problem · 0

    ON MARCH 21, 2025, A GE HEALTHCARE (GEHC) TECHNICAL SUPPORT ENGINEER WAS INFORMED BY A CUSTOMER THAT A PATIENT SUSTAINED A RADIATION INJURY TO THE SKIN FOLLOWING A LENGTHY PROCEDURE WITH A GE HEALTHCARE INNOVA 4100 SYSTEM ON (B)(6), 2025. AN INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022612 INNOVA 4100 INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other