BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRIGHTSPEED

    MDR report key: 2001142 · Received February 18, 2011

    Report

    Report Number
    9613445-2011-00001
    Event Type
    Other
    Date Received
    February 18, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 18, 2011
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    JAK
    PMA / PMN Number
    K082816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S MEASUREMENT AND EVALUATION OF THE SCAN PARAMETERS USED BY THE SITE FOR THESE EXAMINATIONS SHOWS THAT THE CUMULATIVE DOSE ADMINISTERED TO THE PATIENT AT A SINGLE LOCATION WAS ABOVE THE RECOGNIZED THRESHOLD LEVEL FOR DETERMINISTIC EFFECTS SUCH AS SKIN REDDENING AND TEMPORARY HAIR LOSS. THE SYSTEM WAS EVALUATED BY GEHC FOR RADIATION OUTPUT. ALL TESTS INDICATED THE SYSTEM IS OPERATING ACCORDING TO SPECIFICATIONS. NO SYSTEM MALFUNCTION WAS REPORTED OR DETERMINED TO EXIST AFTER TROUBLESHOOTING AND INVESTIGATION. PER THE GE HEALTHCARE LEARNING AND REFERENCE GUIDE, THERE IS A NOTE TO REVIEW THE MA VALUE DURING THESE TYPES OF PROCEDURES TO ENSURE IT IS APPROPRIATE FOR THIS EXAM TYPE. THE TECHNIQUES USED DURING THE EXAM WERE REVIEWED BY A GE CT APPLICATION SPECIALIST AND THE TECHNIQUE FACTORS USED DID APPEAR APPROPRIATE GIVEN THE CONTEXT OF THE STUDY. THE OPERATORS ARE LICENSED, TRAINED, AND ARE UNDER SITE-SPECIFIC PROCEDURES CONCERNING PATIENT DOSE AND EXAM PRESCRIPTION. FACILITIES ARE RECOMMENDED TO MONITOR PATIENT DOSE AND TO PAY CLOSE ATTENTION TO ANY EXAM PRESCRIPTION THAT COULD APPROACH LEVELS AS DISCUSSED BY THE FDA AS THRESHOLDS FOR DETERMINISTIC EFFECTS. THIS WAS A CLINICAL DECISION MADE BY THE SITE AND THEY HAVE INDICATED THAT THEY DO NOT CONSIDER IT TO BE AN ERROR OR FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) GUIDED COMBINED RENAL BIOPSY AND CRYOABLATION PROCEDURE. THE COMPLEXITY OF THE EXAM CAUSED IT TO CONTINUE FOR 4 HOURS. AS A RESULT OF USING CT FOR LOCALIZATION, THE PATIENT RECEIVED A RADIATION DOSE OF APPROXIMATELY 2.49 GRAY OVER A SMALL AREA OF HIS ABDOMEN. THERE WAS NO REPORT OF SKIN REDDENING OR HAIR LOSS IMMEDIATELY AFTER THE PROCEDURE. THE PATIENT DID HAVE SLIGHT REDDENING NOTED DURING A SUBSEQUENT CHECK-UP, HOWEVER, THE REDDENING WAS DIAGNOSED AS DUE TO SKIN AGITATION FROM THE EXPOSURE, SUCH AS FROM BANDAGE AND TAPE REMOVAL, AND NOT SKIN ERYTHEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIGHTSPEED COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK GE HANGWEI MEDICAL SYSTEMS CO., LTD. 5143716-2

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other