BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA

    MDR report key: 21591947 · Received March 13, 2025

    Report

    Report Number
    9611343-2025-00004
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    January 28, 2025
    Report Date
    May 5, 2025
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K122457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCAREÂS INVESTIGATION IS COMPLETE. DEVICE LOGS HAVE BEEN ANALYZED AS PART OF THE INVESTIGATION AND IT WAS DETERMINED THAT SYSTEM WORKS PER SPECIFICATION. THE HIGH DOSE RECEIVED BY THE PATIENT WAS DUE TO EXCESSIVE DSA TIME CHOSEN BY THE CUSTOMER. THE CUSTOMIZED LOW DOSE PROTOCOL, USUALLY USED ON THIS SYSTEM, WAS NOT SELECTED FOR THIS EXAM. GE HEALTHCARE CLINICAL EDUCATION SPECIALISTS HAVE TRAINED DOCTORS AND STAFF ON DOSE SETTINGS. THIS WAS DETERMINED TO BE AN ISOLATED EVENT WITH THE ROOT CAUSE OF CUSTOMER DECISION. NO FURTHER ACTIONS PLANNED BY GE HEALTHCARE.

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS BUC - 283 RUE DE LA MINIERE FRANCE BUC YVELINES, 78530.

    Description of Event or Problem · 0

    CUSTOMER REPORTED TO GE HEALTHCARE THAT A PATIENT HAS BEEN OVER EXPOSED TO RADIATION, IT MAY BE CAUSED BY A LONG FLUORO PROCEDURE. NO PATIENT IMPACT HAS BEEN REPORTED. GE HEALTHCARE INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917113 INNOVA INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS IGS 530 002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown