BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIEHM IMAGING

    MDR report key: 977566 · Received April 30, 2007

    Report

    Report Number
    2027299-2007-00001
    Event Type
    Malfunction
    Date Received
    April 30, 2007
    Date of Event
    April 26, 2007
    Report Date
    April 30, 2007
    Manufacturer
    ZIEHM IMAGING, INC.
    Product Code
    JAA
    PMA / PMN Number
    K851031
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ZIEHM ATTEMPTED FOR OVER 6 WEEKS TO RECOVER THE HAND SWITCH FROM BOTH THE FACILITY AND THE THIRD PARTY SERVICE COMPANY WITHOUT SUCCESS. BASED ON THE INITIAL REPORT BY THE BIOMEDICAL ENGINEER AND SUBSEQUENT INVESTIGATION WITH THEM, RADIATION EXPOSURE HAND SWITCH EXPERIENCED AN INTERMITTENT SHORT WHICH CAUSED THE EXPOSURE WITHOUT USER ACTIVATION. THE ZIEHM EXPOSCOP 7000 HARDWARE SAFETY CONTROL ARE DESIGNED TO MINIMIZE ERRORS FROM HAND AND FOOT SWITCHES. THE SAFETY CIRCUITS MEASURE CONTINUITY FOR SHORTS, ACCIDENTAL CLOSURES AND OPENED SWITCHES OF THE EXPOSURE SWITCHES DURING STARTUP. IF AT STARTUP THESE ERRORS ARE DETECTED, ERROR CODES ARE DISPLAYED TO THE USER AS A WARNING. IF A SHORTED HAND SWITCH IS DETECTED THE SAFETY WATCHDOG CIRCUIT WILL PREVENT RADIATION. ZIEHM THEN TRIED TO SIMULATE THE REPORTED FAULT, BY TESTING NEW HAND SWITCHES FROM IT'S INVENTORY. IN ALL CONDITIONS THE HAND SWITCH DEMONSTRATED NO FAULTS. ZIEHM THEN SIMULATED THE FAULT BY SHORTING THE WIRES OF THE HAND SWITCH BEFORE AND AFTER THE STARTUP OF THE DEVICE. ZIEHM WAS THEN ABLE TO CAUSE A SIMILAR FAULT AS REPORTED WHEN SHORTING WIRES AFTER STARTUP. SYSTEM SAFETY CIRCUIT WORKED ON STARTUP BY BLOCKING RADIATION WITH SHORT IN HAND SWITCH. ZIEHM CONSIDERS THE REPLACEMENT OF THE EXPOSURE HAND SWITCH BY THE FACILITY AS AN APPROPRIATE SERVICE CORRECTION FOR THIS REPORTED FAULT. ZIEHM FURTHER FINDS NO EVIDENCE BASED ON THIS REPORT FOR CONCERN FOR THE SAFETY AND EFFECTIVENESS OF THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE BIOMEDICAL ENGINEERING MGR OF THE FACILITY THAT A PT WAS EXPOSED TO AN ADD'L AMOUNT OF FLUOROSCOPIC X-RAY WITHOUT ACTIVATION BY THE USER PRESSING THE EXPOSURE HAND SWITCH DURING A FLUOROSCOPIC PROCEDURE. THE OPERATOR OBSERVED WHILE POSITIONING THE C-ARM DEVICE OVER THE PT THAT THE RADIATION SAFETY INDICATOR ABOVE THE IMAGE DISPLAY MONITORS WAS ON. THE USER INDICATED THAT THE HAND SWITCH HAD NOT BEEN ACTIVATED. THE OPERATOR TURNED OFF THE C-ARM DEVICE TO PREVENT FURTHER EXPOSURE AND CALLED THE BIOMEDICAL DEPT OF THE FACILITY TO INVESTIGATE. AFTER DISCUSSIONS WITH THE FACILITY BIOMEDICAL ENGINEERING MGR, IT WAS DETERMINED THAT THE PT WAS EXPOSED TO ONE UNATTENDED RADIATION OCCURRENCE WITH AN EXPOSURE TIME OF 5 TO 15 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIEHM IMAGING EXPOSCOP 7000 MOBILE C-ARM JAA ZIEHM IMAGING, INC. EXPOSOCOP 7000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other