BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 2000

    MDR report key: 11700138 · Received April 21, 2021

    Report

    Report Number
    9611343-2021-00001
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    February 5, 2021
    Report Date
    June 1, 2021
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K022322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 74 MINUTES WITH A LOCALIZED PEAK INCIDENT DOSE OF 8,5 GY. SYSTEM CALIBRATIONS WERE WITHIN SPECIFICATIONS. NO INJURY WAS REPORTED. THE HIGH RADIATION RECEIVED BY THE PATIENT WAS DUE TO THE NEEDS OF THE PROCEDURE. THERE WAS NO ISSUE WITH THE GE DEVICE WHICH PERFORMED AS INTENDED. THE MOST PROBABLE ROOT CAUSE FOR THIS HIGH DOSE EXAM IS A SELECTION OF PROTOCOL WITH HIGH 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. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ALL PATIENT INFORMATION WAS NOT YET PROVIDED BY THE CUSTOMER DUE TO HIPPA REGULATIONS. 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.

    Description of Event or Problem · 1

    ON MARCH 31, 2021, GE HEALTHCARE ENGINEERING TEAM DISCOVERED THAT DURING AN EXAM PERFORMED ON (B)(6) 2021, A PATIENT RECEIVED A HIGH RADIATION DOSE DURING AN EXAM. PATIENT RECEIVED A LOCALIZED PEAK SKIN DOSE OF 8.5GY IN THE SAME BODY AREA. NEITHER RADIATION BURN NOR ADVERSE EFFECT TO THE PATIENT HAS BEEN REPORTED BY THE CUSTOMER. THIS EVENT IS REPORTED AS SERIOUS INJURY WHEREAS THERE IS NO ACTUAL INJURY ON THE PATIENT BECAUSE IT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597872 INNOVA 2000 INNOVA 2000 OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other