BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA IGS 630

    MDR report key: 12982287 · Received December 13, 2021

    Report

    Report Number
    9611343-2021-00003
    Event Type
    Injury
    Date Received
    December 13, 2021
    Date of Event
    July 13, 2021
    Report Date
    December 13, 2021
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K181403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION ARE NOT PROVIDED YET. 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. FULL UDI IS (B)(4). INITIAL REPORTER EMAIL ADDRESS NOT PROVIDED. MANUFACTURING DATE WILL BE COMPLETED IN THE FOLLOW-UP REPORT. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ON (B)(6) 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 7,3 GY 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
    1887939 INNOVA IGS 630 INNOVA IGS 630 OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other