BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA IGS 530

    MDR report key: 8854280 · Received August 2, 2019

    Report

    Report Number
    9611343-2019-00007
    Event Type
    Injury
    Date Received
    August 2, 2019
    Date of Event
    July 13, 2019
    Report Date
    September 18, 2019
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K181403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A1, A2 AND A4 : ALL PATIENT INFORMATION ARE DOCUMENTED. BLOCK G5 : 510K REFERENCE IS K181403. 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 2 HOURS AND 30 MIN WITH A LOCALIZED PEAK INCIDENT DOSE OF 9.021 GY. SYSTEM CALIBRATIONS WERE WITHIN SPECIFICATIONS. NO SYSTEM MALFUNCTION HAS BEEN IDENTIFIED. THE MOST PROBABLE ROOT CAUSE FOR THIS HIGH DOSE EXAM IS AN INAPPROPRIATE SELECTION OF PROTOCOL AND EXPOSURE SETTINGS FOR AN EXAM ON A LARGE PATIENT. THOSE SETTINGS ARE DETERMINED BY THE PHYSICIAN BASED ON HER/HIS CLINICAL JUDGMENT FOR THE EXAM NEEDS. 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. EVEN THOUGH THE CUSTOMER WAS ALREADY TRAINED, GEHC FIELD SERVICE ENGINEER STRONGLY RECOMMENDED A DOSE REFRESHER TRAINING TO THE CUSTOMER SEEING THE NON-OPTIMUM SELECTION OF PROTOCOL AND EXPOSURE SETTINGS FOR THIS HIGH DOSE EXAM CASE, BUT CUSTOMER DENIED ANY NEW TRAINING FROM GE HEALTHCARE. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ALL PATIENT INFORMATION WAS NOT YET PROVIDED BY THE CUSTOMER. 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. UNIQUE DEVICE IDENTIFIER IS : (B)(4). (B)(6). 510K REFERENCE WILL BE PROVIDED IN FOLLOW UP REPORT. 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

    A PATIENT RECEIVED A HIGH RADIATION DOSE DURING AN EXAM THAT WAS PERFORMED ON (B)(6) 2019. TOTAL EXAM DOSE WAS 10.348 GY DURING WHICH PATIENT RECEIVED A LOCALIZED PEAK SKIN DOSE OF 9 GY IN THE SAME BODY AREA. PATIENT DID NOT HAVE INJURY FOLLOWING THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650050 INNOVA IGS 530 INNOVA IGS 530 OWB GE MEDICAL SYSTEMS SCS XCA356

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other