BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 4100-IQ

    MDR report key: 4349342 · Received December 22, 2014

    Report

    Report Number
    9611343-2014-00079
    Event Type
    Injury
    Date Received
    December 22, 2014
    Date of Event
    November 23, 2014
    Report Date
    November 24, 2014
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K052412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION HAS BEEN COMPLETED. GE HEALTHCARE WAS INFORMED THAT DURING A LONG, COMPLICATED EMBOLIZATION PROCEDURE ON AN OBESE PATIENT PERFORMED ON (B)(6) 2014. A PATIENT RECEIVED A RADIATION DOSE OF APPROXIMATELY 10 GY. THE EXAM WAS COMPLETED SUCCESSFULLY AND THE PATIENT UNDERGOING THIS PROCEDURE DID NOT SUSTAIN ANY RADIATION INDUCED INJURY. THE SYSTEM WAS FOUND TO BE OPERATING PER SPECIFICATIONS DURING THE EXAM, AND THERE IS NO EVIDENCE OF ANY SYSTEM MALFUNCTION. THE FLUOROSCOPY MAXIMUM DOSE RATES, THE SYSTEM AUTOMATIC EXPOSURE CONTROL AND THE DOSE DISPLAY ON THE SYSTEM WERE OPERATING AS SPECIFIED. THE HIGH DOSE OBSERVED FOR THIS CASE WAS MOST PROBABLY CAUSED BY A LONG AND COMPLEX INTERVENTIONAL PROCEDURE ON A LARGE PATIENT WITH SEVERAL HIGH DOSE DSA (DIGITAL SUBTRACTED ACQUISITION) ACQUISITIONS. THE CHOICE OF ACQUISITION SETTINGS DURING THE EXAM COULD HAVE CONTRIBUTED TO HIGH DOSE OBSERVED FOR THIS EXAM. THE ACQUISITION SETTINGS COULD HAVE BEEN MODIFIED TO REDUCE THE OVERALL EXAM DOSE; HOWEVER, THESE WERE BASED ON THE PHYSICIAN'S CLINICAL JUDGMENT AND PART OF THE RISK/BENEFIT BALANCE. DETAILED INSTRUCTIONS ON REDUCING DOSE AND IMPROVING THE IMAGE QUALITY ARE PROVIDED IN THE INNOVA® 2100-IQ, 3100/3100-IQ, 4100/4100-IQ CARDIOVASCULAR IMAGING SYSTEM OPERATOR MANUAL (5183876-2-299). ON (B)(6) 2015, GE HEALTHCARE'S CLINICAL EDUCATION LEADER CONFIRMED THAT THE CUSTOMER WAS TRAINED IN DOSE REDUCTION FEATURES ON THEIR INNOVA 4100-IQ SYSTEM DURING THE APPLICATION TRAINING THAT WAS PROVIDED TO THE CUSTOMER ON (B)(6) 2007 AND ON (B)(6) 2009. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AGE, SEX, AND WEIGHT WERE NOT PROVIDED. INITIAL REPORTER EMAIL WAS NOT PROVIDED. THIS HIGH AIR-KERMA DOSE, POSSIBLY NOT REDUCED TO THE LOWEST BY USING DOSE REDUCTION FEATURES PROVIDED BY THE SYSTEM, IS LIKELY TO RESULT IN A SERIOUS INJURY BECAUSE IT MAY TAKE SOME TIME BEFORE HAVING ANY RADIATION BURN. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    NO INJURY HAS BEEN REPORTED. IT WAS REPORTED THAT A PATIENT RECEIVED A RADIATION DOSE OF APPROXIMATELY 10 GY, WHILE BEING SCANNED DURING A LONG EXAMINATION WITH AN INNOVA 4100-IQ SYSTEM. THERE WAS NO SYSTEM FAILURE OR MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841321 INNOVA 4100-IQ INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS XVA322

    Patients

    Seq Age Sex Outcome Treatment
    1 Other