BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRILLIANCE 64

    MDR report key: 1660880 · Received March 19, 2010

    Report

    Report Number
    1525965-2010-00003
    Event Type
    Other
    Date Received
    March 19, 2010
    Date of Event
    August 13, 2010
    Report Date
    February 22, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN FOR THE CAUSE OF THE PT'S BLINDNESS BASED UPON THE AVAILABLE INFO. HOWEVER, SERVICE RECORDS INDICATE A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND PERFORMED MAINTENANCE ON THE SCANNER IN (B)(4) (PRIOR TO THE EVENT) AND (B)(4) (AFTER THE EVENT). THERE IS NO INDICATION IN PHILIPS HEALTHCARE RECORDS THAT WOULD INDICATE A PROBLEM WITH THE DOSE THAT IS DELIVERED TO A PT. (B)(4).

    Description of Event or Problem · 1

    THIS MDR IS BEING SUBMITTED IN RESPONSE TO MEDWATCH (B)(6). THIS MEDWATCH WAS SUBMITTED BY A PT WHO STATES THAT A 543 MGY DOSE WAS DELIVERED FOR A NECK SCAN ON (B)(6) 2009. AFTER THE SCAN, THE PT EXPERIENCED A RAPIDLY PROGRESSING CATARACT OF THE RIGHT EYE WHICH RESULTED IN BLINDNESS. THE PT IS QUESTIONING IF THE NECK SCAN COULD HAVE RESULTED IN BLINDNESS. PHILIPS HEALTHCARE FOLLOWS THE INDUSTRY STANDARD FOR GUIDANCE IN OUR SCANS. THE MOST RECENT GUIDANCE FOR DETERMINISTIC RADIATION EFFECTS FOR EYE LENS (ACUTE DOSE THRESHOLD) IS APPROXIMATELY 0.5-2 GY FOR OPACITIES AND 2-10 GY FOR VISUAL IMPAIRMENT (ICRP 103 TABLE A.3.1.). FOR A PT TO SUFFER ANY SIGNIFICANT DAMAGE AS STATED ABOVE, THE PT WOULD HAVE TO RECEIVE AT LEAST 5 GY OF RADIATION WHICH WOULD MOST LIKELY FIRST RESULT IN EPILATION AND ERYTHEMA AS AN INDICATOR OF EXCESSIVE RADIATION DOSE. THESE EFFECTS WERE NOT REPORTED IN THIS EVENT. NOTE: THE DOSE OF 543 MGY IS CONSISTENT WITH THIS TYPE OF PROCEDURE. RADIATION INDUCED CATARACTS USUALLY INVOLVE A MODERATE LATENT PERIOD (YEARS) BEFORE EFFECTS ARE SHOWN. PHILIPS HEALTHCARE DOES NOT BELIEVE THAT THE INDICATED DOSE OF RADIATION COULD HAVE CAUSED BLINDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE 64 X-RAY CT SCANNER SYSTEM/JAK JAK PHILIPS HEALTHCARE 728231

    Patients

    Seq Age Sex Outcome Treatment
    1