BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSPEED 16 SLICE

    MDR report key: 1943712 · Received December 16, 2010

    Report

    Report Number
    2126677-2010-00014
    Event Type
    Other
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 16, 2010
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K013561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE MEASUREMENT AND EVAL OF THE SCAN PARAMETERS USED BY THE SITE FOR THESE EXAMINATIONS SHOWS THAT THE DOSE ADMINISTERED TO THE PTS WAS MARGINALLY BELOW THE RECOGNIZED THRESHOLD LEVEL FOR DETERMINISTIC EFFECTS SUCH AS SKIN REDDENING AND TEMPORARY HAIR LOSS. NO SYS MALFUNCTION WAS REPORTED OR DETERMINED TO EXIST AFTER TROUBLESHOOTING AND INVESTIGATION. GE DOES NOT PROVIDE INTERVENTIONAL BIOPSY REFERENCE PROTOCOLS. THE PROTOCOL IN QUESTION WAS A CUSTOMER BUILT PROTOCOL USED FOR SACRO ILIAC JOINT INJECTION AND WAS SELECTED AS IT WAS PRESET TO ALLOW THE PT TO BE IN THE PRONE POSITION. SINGLE USE OF THIS PROTOCOL DURING THE SAME PROCEDURE WITHOUT COMPLICATION WOULD YIELD A MUCH LOWER TOTAL DOSE TO THE PT, HOWEVER AFTER REVIEW BY APPLICATIONS, THIS WAS FOUND TO BE A NON-STANDARD USE OF THE PROTOCOL FOR AN INTERVENTIONAL PROCEDURE. FOLLOWING THE EVENT, THE SITE HAS NOW CREATED SCANNING PROTOCOLS AND THE DEPARTMENT HAS IN-SERVICED ALL CT STAFF AND THREE CREDENTIALED RADIOLOGISTS. IN THE EVENT THAT ANOTHER DIFFICULT AND COMPLEX CASE OF THIS NATURE SURFACES, THE SITE CAN ASSURE THAT ALL FUTURE DOSES WILL BE SIGNIFICANTLY REDUCED TO FALL WITHIN INTERVENTIONAL PROCEDURE STANDARDS. PER THE GE HEALTHCARE LEARNING AND REFERENCE GUIDE, THERE IS A NOTE TO REVIEW THE MA VALUE TO ENSURE IT IS APPROPRIATE FOR THIS EXAM TYPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PRESENTED FOR CT-GUIDED PERCUTANEOUS NEPHROSTOMY TUBE PLACEMENT. THE EXAM WAS DIFFICULT AND COMPLEX DUE TO THE PT'S ANATOMY DUE TO AN UNDERLYING BLADDER TUMOR. THE PROCEDURE TYPICALLY TAKES ONLY 1/2 HR, HOWEVER THE COMPLEXITY CAUSED THE EXAM TO CONTINUE FOR 4 HOURS, AS IT REQUIRED THE HELP OF THE UROLOGIST AND 3 TRIES TO BE SUCCESSFUL. AS A RESULT OF USING CT FOR LOCALIZATION, THE PT RECEIVED A RADIATION DOSE OF APPROX 1.98 MGY OVER A 10 MM AREA OVER THE SMALL OF THE PT'S BACK. CONCERNS FOR ADVERSE OUTCOME LED TO OVERNIGHT OBSERVATION. PT WAS HOSPITALIZED FOR ADDITIONAL SURGICAL PROCEDURES THAT EXTENDED HIS STAY FOUR ADDITIONAL DAYS. THERE WAS NO REPORT OF SKIN REDDENING OR HAIR LOSS AFTER MONITORING OF THE PT FOLLOWING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSPEED 16 SLICE JAK GE MEDICAL SYSTEMS, LLC 2339985

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| O