BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOSHIBA AP X-RAY TUBE /2. IMAGE INTENSIFIER

    MDR report key: 23768 · Received July 12, 1995

    Report

    Report Number
    23768
    Event Type
    Other
    Date Received
    July 12, 1995
    Date of Event
    October 3, 1994
    Report Date
    July 12, 1995
    Manufacturer
    TOSHIBA MEDICAL
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT LEFT CARDIAC CATHERIZATION WITH MULTIPLE PTCA'S AND STENT PLACEMENT FLUOROSCALLY GUIDED. THE FLUOROSCOPE WAS USED FOR A TOTAL OF 113 MINUTES WITH HIGH DOSE MODE OPERATING AT TIMES DURING THE PROCEDURE. 2 DAYS POST-CATHERIZATION. PT WAS NOTED TO HAVE 2 AREAS OF BURNS ON HIS RIGHT BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA AP X-RAY TUBE /2. IMAGE INTENSIFIER TOSHIBA AP X-RAY TUBE /2. IMAGE INTENSIFIER JAA TOSHIBA MEDICAL 1. TSUA-2 2. OP92SE

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other