BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSPEED

    MDR report key: 2543143 · Received April 5, 2012

    Report

    Report Number
    2126677-2012-00038
    Event Type
    Other
    Date Received
    April 5, 2012
    Date of Event
    August 5, 2011
    Report Date
    March 8, 2012
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K030420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS COMPLETE, THE TEST RESULTS FOR THE CT SYSTEM SHOW NO ISSUES THAT CAUSED OR CONTRIBUTED TO THE ALLEGED BURN. THE SYSTEM WAS DETERMINED TO BE FUNCTIONING WITHIN SPECIFICATIONS AND THERE WAS NO SYSTEM MALFUNCTION. THE PT DOSE VALUES DELIVERED TO THE AREA OF CONCERN WERE APPROXIMATELY 78 TIMES LESS THAN THE THRESHOLD FOR DETERMINISTIC EFFECTS OF 2GY. ADDITIONALLY THE SCAN AREA RECEIVING THE HIGHEST DOSE (PT'S ABDOMEN) WAS UNAFFECTED. THE TECHNICAL REFERENCE MANUAL (TRM) FOR LIGHTSPEED SERIES ((B)(4) REVISION: 5) WAS REVIEWED AND IT PROVIDES ADEQUATE INFO AND WARNINGS FOR THE USER. IT SPECIFICALLY STATES "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." THE ROOT CAUSE OF THE REDNESS AND BLISTERING COULD NOT BE DETERMINED. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALLEGATION OF A RADIATION BURN ON A PT'S INNER THIGHS AFTER BEING SCANNED ON A LIGHTSPEED CT SCANNER. THE PT WAS SEEN IN THE ER THE NEXT DAY FOR REDNESS AND BLISTERING APPROXIMATELY 8 HRS AFTER BEING SCANNED AND THE ER PHYSICIAN DIAGNOSIS WAS ASSESSED AS A CONTRAST ALLERGY. THE HOSP HCP STATED THAT OTHER MEDICAL FACTORS AND CONCURRENT DRUGS WITH SIDE EFFECT PROFILES SIMILAR TO WHAT PT HAD EXHIBITED COULD BE A CONTRIBUTING FACTOR FOR THE REDNESS AND BLISTERING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other