BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 2000

    MDR report key: 1877532 · Received October 13, 2010

    Report

    Report Number
    9611343-2010-00011
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    July 11, 2010
    Report Date
    October 13, 2010
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K022322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION TO GE HEALTHCARE. GE HEALTHCARE'S INVESTIGATION OF THE SYSTEM LOGS AND DICOM DATA REVEAL THAT THE LENGTH OF THE EXAM WAS 4.5 HOURS, WITH 379 SEQUENCES OF FLUOROSCOPY OF 15 FRAMES PER SECOND. THE CUMULATED FLUOROSCOPY TIME WAS 98 MINUTES. THE TOTAL DOSE WAS ESTIMATED TO BE 13.2 GY, CALCULATED BY THE SYSTEM AT INTERVENTIONAL REFERENCE POINT (IRP, 15 CM BELOW ISOCENTER, 55.5 CM FROM SOURCE). SOURCE TO ISOCENTER DISTANCE IS 70.5 CM FROM INNOVA 2000 SYSTEMS. THE TABLE WAS 17 CM BELOW ISOCENTER, MEANING THAT IF THE GANTRY WAS IN POSTERO ANTERIOR (PA), THE SOURCE TO PATIENT DISTANCE WAS 53.5 CM. INNOVA 2000 SYSTEMS DO NOT LOG THE GANTRY ANGULATIONS, THUS THIS DATA IS NOT AVAILABLE. THEORETICAL DOSE ESTIMATION CAN BE MADE WITH THE ASSUMPTION THAT THE GANTRY WAS IN PA, WHICH IS THE NOMINAL CASE. TO SCALE DOSE VALUES FROM IRP (INTERVENTIONAL REFERENCE POINT) TO TABLETOP POSITION, THE INVERSE SQUARE RULE CAN BE APPLIED WITH THE DISTANCES FROM SOURCE. ASSUMING THAT THE GANTRY WAS IN PA DURING THE ENTIRE EXAM, INCIDENT DOSE WOULD BE 13.2 GY * (55.5/53.5) ^2 = 14.2 GY. CONSIDERING 12% TABLE X-RAY ATTENUATION, INCIDENT SKIN DOSE ESTIMATION IS 12.5 GY. THIS VALUE IS ABOVE THE ESTIMATED SKIN DOSE THRESHOLD OF SKIN INJURY. THESE RESULTS WERE PROVIDED TO THE CUSTOMER ON 09/23/2010. AS A KNOWN SIDE EFFECT OF THIS TYPE OF PROCEDURE, PATIENT DOSE ADVERSE EVENTS ARE MOSTLY DRIVEN BY LONG INTERVENTIONAL PROCEDURES. ALL ESSENTIAL FEATURES FOR DOSE REDUCTION ARE AVAILABLE ACROSS ALL GE HEALTHCARE (GEHC) VASCULAR PRODUCTS. GEHC DOES NOT HAVE ALL THE TECHNICAL/CLINICAL PARAMETERS RELATED TO THIS EXAM TO SHOW WHETHER THE X-RAY DOSAGE DELIVERED BY THE EQUIPMENT TO THE PATIENT WAS APPROPRIATE. THE CUSTOMER HAS DECLINED TO PROVIDE FURTHER INFORMATION. SYSTEM LOGS SHOW THAT IQ STANDARD AUTO EXPOSURE PREFERENCE, 15 FRAME PER SECOND RATE, AND NORMAL DETAIL FLUOROSCOPY WAS USED DURING THE EXAM, WHICH IS A MEDIUM DOSE LEVEL SETTING. LOGS DO NOT INDICATE MISUSE OF THE SYSTEM. THE INVESTIGATION INDICATES THAT THE SKIN INJURY WAS LIKELY THE RESULT OF PROLONGED EXAMINATION REQUIRED BY THE INTERVENTIONAL PROCEDURE, IN WHICH THE HOSPITAL STAFF EXPECTED MEDICAL BENEFIT TO THE PATIENT. NO SYSTEM MALFUNCTION WAS IDENTIFIED. ON 06/10/2010, ONE MONTH BEFORE THE REPORTED EXAM, THE SYSTEM WAS CALIBRATED, CHECKED AND FOUND TO BE PER SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER SITE REPORTED THAT A PATIENT SUSTAINED A RADIATION BURN DURING A PROLONGED EMERGENCY CARDIAC PROCEDURE. THERE IS NO ALLEGATION OF EQUIPMENT MALFUNCTION. THE EQUIPMENT WAS REPORTEDLY TESTED BY THE SITE PHYSICIST AND WAS FOUND TO BE IN COMPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2000 VASCULAR X-RAY SYSTEM MQB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1