BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSPEED VCT

    MDR report key: 2050875 · Received April 1, 2011

    Report

    Report Number
    2126677-2011-00024
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    November 16, 2010
    Report Date
    April 1, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K061817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NARRATIVE: NO SYSTEM MALFUNCTION WAS REPORTED OR DETERMINED TO EXIST AFTER TROUBLESHOOTING AND INVESTIGATION. THE SITE PERFORMED AN EVALUATION OF THE DOSE ADMINISTERED TO THE PT (2.51 GY WAS DELIVERED TO THE SINGLE LOCATION). THIS IS GREATER THAN THE RECOGNIZED THRESHOLD LEVEL FOR DETERMINISTIC EFFECTS, SUCH AS SKIN REDDENING AND TEMPORARY HAIR LOSS. THE DOSE PRESCRIBED BY THE SITE WAS SIGNIFICANTLY GREATER THAN GE HEALTHCARE AND THE SITE'S DEFAULT PROTOCOLS. THE GE HEALTHCARE PROVIDED PROTOCOL FOR THIS SCAN TYPE RESULTS IN A PT DOSE THAT IS SIGNIFICANTLY LOWER THAN INDUSTRY AND FDA RECOGNIZED THRESHOLD LEVELS FOR POSSIBLE DETERMINISTIC EFFECTS. THE SITE'S DEFAULT PROTOCOL FOR PERFUSION SCANNING WAS FOUND TO BE IN ACCORDANCE WITH GE HEALTHCARE REFERENCE PROTOCOL RECOMMENDATIONS FOR IMAGING AND DOSE. ACCORDING TO THE SITE, THE TECHNICIAN MANUALLY INCREASED THE MA ON THE EXAM IN ORDER TO ENHANCE THE IMAGE QUALITY, ALTHOUGH IMAGES ON THE SITE'S UNALTERED DEFAULT PROTOCOLS ARE DIAGNOSTIC. GE HEALTHCARE ANALYSIS OF THE PROPOSED SCAN PARAMETERS SHOW THAT IN ORDER TO ACHIEVE DOSE AT THE LEVELS DELIVERED, A SIGNIFICANT INCREASE TO THE KV OUTSIDE OF DEFAULT SYSTEM PARAMETERS MUST HAVE ALSO OCCURRED. THE SITE RETRAINED THEIR STAFF OF TECHNOLOGISTS NOT TO CHANGE THE DEFAULT PROTOCOLS. TECHNIQUES AND DOSE ARE INCORPORATED IN THE SITE'S NEW TECHNOLOGIST TRAINING AND ANNUAL EVALUATIONS. GE HEALTHCARE PRODUCT LABELING SPECIFICALLY WARNS THE OPERATOR WITH THE FOLLOWING STATEMENT: "PROLONGED EXPOSURE TO X-RAY IN ONE SPOT MAY CAUSE REDDENING OR RADIATION BURNS. USER MUST BE AWARE OF THE TECHNIQUES USED AND EXPOSURE TIME TO INSURE SAFE OPERATION."

    Description of Event or Problem · 1

    DURING A REVIEW OF A NY TIMES NEWSPAPER ARTICLE DATED (B)() 2011 IT WAS LEARNED THAT A PT EXPERIENCED LOCALIZED HAIR LOSS AFTER A BRAIN PERFUSION SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSPEED VCT COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK GE MEDICAL SYSTEMS, LLC 5124069-5

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other