BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 3100-IQ

    MDR report key: 4339877 · Received December 12, 2014

    Report

    Report Number
    9611343-2014-00076
    Event Type
    Injury
    Date Received
    December 12, 2014
    Date of Event
    November 13, 2014
    Report Date
    November 13, 2014
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    JAA
    PMA / PMN Number
    K031637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HIGH AIR-KERMA DOSE, NOT POSSIBLY REDUCED TO THE LOWEST BY USING DOSE REDUCTION FEATURES PROVIDED BY THE SYSTEM, IS LIKELY TO RESULT IN A SERIOUS INJURY SINCE 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.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. GE HEALTHCARE'S INVESTIGATION HAS BEEN COMPLETED. GE HEALTHCARE WAS INFORMED THAT DURING A LONG PCI (PERCUTANEOUS CORONARY INTERVENTION) PROCEDURE ON A LARGE PATIENT PERFORMED THE SAME DAY. THE CUMULATIVE EXAM DOSE AROUND 13 GY. THE EXAM WAS SUCCESSFULLY COMPLETED 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. 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 INTERVENTION ON A LARGE PATIENT. THERE IS A POTENTIAL THAT THE SELECTED DOSE PARAMETERS WERE INAPPROPRIATE AND COULD HAVE CONTRIBUTED TO THE HIGH DOSE DELIVERY. 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 3100-IQ SYSTEM OPERATOR MANUAL (5391979-4-399). ON JANUARY 13, 2015, THE GE HEALTHCARE TECHNICAL OPERATION MANAGER CONFIRMED THAT THE CUSTOMER IS WELL-TRAINED AND AWARE ABOUT RADIATION SAFETY. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    NO INJURY HAS BEEN REPORTED. IT WAS REPORTED THAT A PATIENT RECEIVED A RADIATION DOSE ABOVE 12 GY, WHILE BEING SCANNED WITH AN INNOVA 310-IQ SYSTEM DURING AN EMERGENCY CASE. THERE WAS NO SYSTEM FAILURE OR MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808068 INNOVA 3100-IQ INTERVENTIONAL FLUOROSCOPIC X-RAY JAA GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other