BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 4100

    MDR report key: 23552751 · Received November 14, 2025

    Report

    Report Number
    9611343-2025-00011
    Event Type
    Death
    Date Received
    November 14, 2025
    Date of Event
    October 17, 2025
    Report Date
    February 6, 2026
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE HAS COMPLETED ITS INVESTIGATION. DURING THE INCIDENT, THE PATIENT (BETWEEN 60 AND 70 YEARS OLD) WAS ON THE TABLE BUT VERY AGITATED. ADDITIONAL SEDATIVES WERE ADMINISTRATED. SHORTLY AFTER, THE PATIENT FELL OFF TOWARD THE LEFT SIDE APPROXIMATELY 2.5-3 FT, IMPACTING HIS HEAD AND RESULTING IN A SUBDURAL HEMATOMA. DUE TO MULTIFACTORIAL COMPLICATIONS, THE PATIENT DIED THREE DAYS LATER. PATIENT RESTRAINTS ARE AVAILABLE ON THE TABLE AND RECOMMENDED FOR USE PER THE OPERATOR MANUAL. HOWEVER, IN THIS CASE, THESE RESTRAINTS WERE NOT USED TO MAINTAIN THE PATIENT, EVEN WHEN HE WAS VERY AGITATED. THE SYSTEM HAS BEEN INSPECTED AND WAS MEETING ALL SPECIFICATIONS. A MEETING WITH THE CUSTOMER WAS HELD TO REVIEW THE EVENT AND SHARE THE INVESTIGATION FINDINGS AND DISCUSS THE APPROPRIATE USE OF PATIENT RESTRAINTS. THE RISK ANALYSIS DETERMINED THAT NO ADDITIONAL MITIGATIONS ARE AVAILABLE TO REDUCE THE RISK, AND THE RISK HAS BEEN REDUCED AS FAR AS POSSIBLE. NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE.

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS BUC - 283 RUE DE LA MINIERE FRANCE BUC YVELINES, 78530. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. UDI NOT APPLICABLE: DEVICE MANUFACTURED PRIOR TO THE IMPLEMENTATION OF UDI REQUIREMENTS.

    Description of Event or Problem · 0

    PLEASE SEE H11.

    Description of Event or Problem · 0

    GE HEALTHCARE HAS BEEN INFORMED THAT DURING A VASCULAR PROCEDURE, A PATIENT FELL FROM THE TABLE. IT WAS LATER REPORTED THAT THE PATIENT HAD A HEMATOMA AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928991 INNOVA 4100 INTERVENTIONAL FLUOROSCOPIC SYSTEM OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death