BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA IGS 320

    MDR report key: 7047877 · Received November 21, 2017

    Report

    Report Number
    9613445-2017-00004
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    May 12, 2017
    Report Date
    January 8, 2018
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    OWB
    PMA / PMN Number
    K111209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS REPORTED AS SERIOUS INJURY WHEREAS IT IS CURRENTLY A MINOR INJURY. HOWEVER THIS EVENT IS LIKELY TO RESULT IN A SERIOUS INJURY WITH REGARDS TO THE AMOUNT OF RADIATION RECEIVED BY THE PATIENT, AND 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.

    Additional Manufacturer Narrative · 1

    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 DURATION WAS ABOUT 4 H 53 MIN AND THE TOTAL EXAM DOSE WAS 9.9 GY WITH A LOCALIZED PEAK INCIDENT DOSE OF 9.3 GY. SYSTEM CALIBRATIONS WERE WITHIN SPECIFICATIONS. NO SYSTEM MALFUNCTION HAS BEEN IDENTIFIED. THE MOST PROBABLE ROOT CAUSE FOR THIS HIGH DOSE EXAM WAS A LONG EXAM PERFORMED ON A LARGE PATIENT WITH HIGH DOSE ACQUISITION SETTINGS, EVEN IF A DIFFERENT CHOICE OF ACQUISITION SETTINGS COULD STILL HAVE REDUCED THE EXAM DOSE. HOWEVER, THE SETTINGS WERE DETERMINED BASED ON THE PHYSICIAN¿S CLINICAL JUDGMENT. DETAILED DOSE REDUCTION INSTRUCTIONS ARE CLEARLY PROVIDED IN THE OPTIMA IGS 320 OPERATOR MANUAL (5485491-1-399). THESE INSTRUCTIONS HAVE BEEN REVIEWED AND FOUND TO BE APPROPRIATE. PROPER TRAINING WAS GIVEN TO THE CUSTOMER ON DOSE PROTOCOL DURING SYSTEM INSTALLATION. ON DECEMBER 14, 2017 A DOSE REFRESHER TRAINING HAS BEEN GIVEN TO THE CUSTOMER BY GE HEALTHCARE APPLICATION SPECIALIST. THE SYSTEM WORKED AS INTENDED AND PER SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT RECEIVED A HIGH RADIATION DOSE DURING AN EXAM THAT WAS PERFORMED ON (B)(6) 2017. TOTAL EXAM DOSE WAS 9.9 GY DURING WHICH PATIENT RECEIVED A LOCALIZED PEAK SKIN DOSE OF 9.3 GY IN THE SAME BODY AREA. CUSTOMER REPORTED THAT THE PATIENT HAD A REDNESS TO THE HAIR ROOT FOLLOWING THIS EXAM, WHICH IS CONSIDERED AS A MINOR INJURY BUT IS LIKELY TO RESULT IN A SERIOUS INJURY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT RECEIVED A HIGH RADIATION DOSE DURING AN EXAM THAT WAS PERFORMED ON (B)(6) 2017. TOTAL EXAM DOSE WAS 9.9 GY DURING WHICH PATIENT RECEIVED A LOCALIZED PEAK SKIN DOSE OF 9.3 GY IN THE SAME BODY AREA. CUSTOMER REPORTED THAT THE PATIENT HAD A REDNESS TO THE HAIR ROOT FOLLOWING THIS EXAM, WHICH IS CONSIDERED AS A MINOR INJURY BUT IS LIKELY TO RESULT IN A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830766 OPTIMA IGS 320 INTERVENTIONAL FLUOROSCOPIC X RAY OWB GE HANGWEI MEDICAL SYSTEMS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other