BEUDAMED
    FDA Adverse Event Other Summary report: N

    FISCHER IMAGING BI-PLANE

    MDR report key: 277222 · Received May 11, 2000

    Report

    Report Number
    277222
    Event Type
    Other
    Date Received
    May 11, 2000
    Date of Event
    March 20, 2000
    Report Date
    May 10, 2000
    Manufacturer
    FISCHER IMAGING CORP
    Product Code
    JAA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    ON THURSDAY, MARCH 16, 2000, CLINICAL ENGINEERING WAS NOTIFIED THAT THE FLUOROSCOPIC SYSTEM IN THE ELECTROPHYSIOLOGY LAB HAD BEEN HAVING INTERMITTENT FAILURES, IN WHICH THE SYSTEM HAD TO BE RESET TO CONTINUE OPERATION. THE UNIT WAS TESTED AND AFTER A FEW MINUTES OF FLUORO TIME, THE GENERATOR PRODUCED AN ERROR CODE (7-). CLINICAL ENGINEERING TECHNICIAN CONTACTED THE FISCHER TECHNICAL SUPPORT REPRESENTATIVE AND TECHNICAL SERVICE EDUCATOR. CLINICAL ENGINEERING TECHNICIAN WAS ABLE TO CONFIRM THAT THE ERROR WAS CAUSED BY A THERMAL SWITCH OPENING ON THE GENERATOR AND THAT THE THERMAL SWITCH SHOULD BE REPLACED. THE SWITCH WAS ORDERED AND RECEIVED THE NEXT DAY, FRIDAY, MARCH 17, 2000 AND REPLACED. THERE WERE NO CASES UNTIL MONDAY, MARCH 20. DURING A FLUOROSCOPICALLY SUPPORTED ELECTROPHYSIOLOGY PROCEDURE, ON MARCH 20, THE AP TUBE OF THE BIPLANE UNIT WHILE BEING OPERATED IN THE PULSED AND CONTINUOUS MODES SHUTDOWN SEVERAL TIMES. THE SYSTEM WAS ALLOWED TO STAND FOR A SHORT PERIOD AND THEN WAS RESTARTED. WHEN THE PROBLEM PERSISTED DURING A SUBSEQUENT CASE ON MARCH 21, CLINICAL ENGINEERING TECHNICIAN CONTACTED MEDICAL PHYSICS/RADIATION SAFETY PERSONNEL TO EVALUATE THE EXPOSURE RATE; IT WAS DETERMINED THAT THERE HAD BEEN A FAILURE OF THE GRID TANK WHICH CONTROLLED THE X-RAY PRODUCTION IN THE PULSED MODE. THE SHUTDOWN OCCURRED ONLY AFTER THE UNIT HEAT LOAD HAD BEEN EXCEEDED. HOWEVER, PRIOR TO THIS SAFETY MECHANISM TAKING OVER IT IS BELIEVED THAT WHEN THE SYSTEM WAS OPERATED IN PULSE MODE, RATHER THAN A SERIES OF LOW DOSE PULSES BEING PRODUCED, A CONTINUOUS UNINTERRUPTED PULSE WAS PRODUCED. MEASUREMENT OF BEAM OUTPUT USING A CALIBRATED EXPOSURE RATE METER YIELDED AN OUTPUT THAT WAS GREATER THAN 10 ROENTGEN PER MINUTE FOR THE 15 PULSES PER SECOND MODE AND A NOMINAL 1 ROENTGEN PER MINUTE FOR THE CONTINUOUS FLUOROSCOPIC MODE. THIS CONTINUED UNTIL THE SUBSTANTIAL HEAT THAT WAS GENERATED CAUSED THE SYSTEM TO SHUTDOWN. THE PT RECEIVED A TOTAL OF 189 MINUTES OF COMBINED FLUOROSCOPIC TIME, SPLIT BETWEEN THE LATERAL TUBE AND THE AP TUBE (CONTINUOUS AND WHAT WAS BELIEVED TO BE 15 PULSES PER SECOND MODE).

    Description of Event or Problem · 2

    DURING A FLUOROSCOPICALLY SUPPORTED ELECTROPHYSIOLOGY PROCEDURE THE AP TUBE OF THE BIPLANE UNIT WHILE BEING OPERATED IN THE PULSED AND CONTINUOUS MODES SHUTDOWN SEVERAL TIMES. THE SYSTEM WAS ALLOWED TO STAND FOR A SHORT PERIOD AND THEN RESTARTED. THE CLINICAL ENGINEERING TECHNICIAN CONTACTED MEDICAL PHYSICS/RADIATION SAFETY PERSONNEL TO EVALUATE THE EXPOSURE RATE; IT WAS DETERMINED THAT THERE HAD BEEN A FAILURE OF THE GRID TANK WHICH CONTROLLED THE X-RAY PRODUCTION IN THE PULSED MODE. THE SHUTDOWN OCCURRED ONLY AFTER THE UNIT HEAT LOAD HAD BEEN EXCEEDED, HOWEVER, PRIOR TO THIS SAFETY MECHANISM TAKING OVER IT IS BELIEVED THAT WHEN THE SYSTEM WAS OPERATED IN PULSE MODE, RATHER THAN A SERIES OF LOW DOSE PULSES BEING PRODUCED; A CONTINUOUS UNINTERRUPTED PULSE WAS PRODUCED. MEASUREMENT OF BEAM OUTPUT USING A CALIBRATED EXPOSURE RATE METER YIELDED AN OUTPUT THAT WAS GREATER THAN OF 10 ROENTGEN PER MINUTE FOR THE 15 PULSES PER SECOND MODE AND A NOMINAL 1 ROENTGEN PER MINUTE FOR THE CONTINUOUS FLUOROSCOPIC MODE. THIS CONTINUED UNTIL THE SUBSTANTIAL HEAT THAT WAS GENERATED CAUSED THE SYSTEM TO SHUTDOWN. THE PT RECEIVED A TOTAL OF 190 MINUTES OF COMBINED FLUOROSCOPIC TIME, SPLIT BETWEEN THE LATERAL TUBE AND THE AP TUBE(CONTINUOUS AND WHAT WAS BELIEVED TO BE 15 PULSES PER SECOND MODE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FISCHER IMAGING BI-PLANE FLUOROSCOPIC X-RAY JAA FISCHER IMAGING CORP 80HF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other
    2 68 YR Other