BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA IGS 520

    MDR report key: 12576611 · Received October 5, 2021

    Report

    Report Number
    9611343-2021-00002
    Event Type
    Injury
    Date Received
    October 5, 2021
    Date of Event
    July 1, 2020
    Report Date
    November 22, 2021
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K181403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NARRATIVE BLOCK H6: GE HEALTHCARE INVESTIGATION OF THIS EVENT WAS PERFORMED USING INFORMATION PROVIDED BY GE HEALTHCARE FIELD SERVICE ENGINEER AND LOGS FROM THE SYSTEM WHICH SHOWED THAT THE TOTAL EXAM ACQUISITION DURATION WAS OF 75 MINUTES WITH A TOTAL DOSE OF 27 GY. SYSTEM CALIBRATIONS WERE WITHIN SPECIFICATIONS. NO SYSTEM MALFUNCTION HAS BEEN IDENTIFIED. THE MOST PROBABLE ROOT CAUSE FOR THIS HIGH DOSE DELIVERY IS THE EXPOSURE RECORD TIME. THOSE SETTINGS ARE DETERMINED BY THE PHYSICIAN BASED ON THE RADIOGRAPHERS CLINICAL JUDGMENT AND PART OF THE RISK/BENEFIT BALANCE. DETAILED DOSE REDUCTION INSTRUCTIONS ARE CLEARLY PROVIDED IN THE INNOVA OPERATOR MANUAL. THESE INSTRUCTIONS HAVE BEEN REVIEWED AND FOUND TO BE APPROPRIATE. PROPER TRAINING WAS GIVEN TO THE CUSTOMER ON DOSE PROTOCOL DURING SYSTEM INSTALLATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NO SYSTEM MALFUNCTION HAS BEEN IDENTIFIED TILL NOW. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    ON (B)(6) 2021, GE HEALTHCARE ENGINEERING TEAM RECEIVED THE CONFIRMATION THAT DURING AN EXAM PERFORMED ON (B)(6) 2020, A PATIENT RECEIVED A HIGH RADIATION DOSE OF 27 GY DURING A MULTI-VESSEL CORONARY ANGIOGRAPHY IN A LARGE PATIENT. THE PATIENT LATER PRESENTED A RADIATION BURN, WHICH WAS TREATED WITH A SKIN GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471672 INNOVA IGS 520 INNOVA IGS 520 OWB GE MEDICAL SYSTEMS SCS IGS 520 OMEGA CERBA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other