BEUDAMED
    FDA Adverse Event Other Summary report: N

    INNOVA 2121-IQ

    MDR report key: 1993430 · Received February 10, 2011

    Report

    Report Number
    9611343-2011-00004
    Event Type
    Other
    Date Received
    February 10, 2011
    Date of Event
    June 17, 2010
    Report Date
    February 9, 2011
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K060259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO BE DETERMINED, LIMITED INFO CONCERNING THIS EVENT IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    A GE HEALTHCARE APPLICATION SPECIALIST DISCOVERED A RADIATION EXPOSURE EVENT DURING AN APPLICATION TRAINING EVENT AND LOG REVIEW ON (B)(6) 2011. A REVIEW OF THE INNOVA (B)(4) SYSTEM LOG FILES REVEALED THAT A PT RECEIVED A CUMULATIVE AIR KERMA OF 34 GRAY DURING AN EXAM THAT WAS COMPLETED ON (B)(6) 2010. A DOSE OF THIS LEVEL MAY RESULT IN A RADIATION BURN, HOWEVER, NO INJURY HAS BEEN REPORTED AT THIS TIME. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2121-IQ VASCULAR X-RAY SYSTEM MQB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other