BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPLORER 1600 WITH SEDECAL X PLUS LP STAND

    MDR report key: 2176691 · Received November 27, 2006

    Report

    Report Number
    9616853-2006-00001
    Event Type
    Malfunction
    Date Received
    November 27, 2006
    Date of Event
    August 29, 2006
    Report Date
    November 24, 2006
    Manufacturer
    SEDECAL SA
    Product Code
    KPR
    PMA / PMN Number
    K012546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGING DYNAMICS COMPANY (IDC) IS REPORTING THIS INCIDENT AS MFR AND SYS INTEGRATOR OF THE X1600 DIGITAL RADIOGRAPHIC SYS (COMPRISING OF THE IDC XPLORER 1000 DETECTOR HEAD AND SEDECAL X PLUS LP RADIOLOGIC STAND). IT WAS DETERMINED THAT THE STAND MALFUNCTION WAS DUE TO INSTALLATION WIRING ERRORS. FURTHER INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE WIRING ERRORS FOUND THAT DURING INSTALLATION, THE LOCATION OF THE XPLORER 1600 SYS WITHIN THE ROOM WAS CHANGED. TO ACCOMMODATE FOR THIS CHANGE, THE STAND AND CABLES WERE REPLACED, BUT THE STAND CONTROL CABINET WAS NOT. IT IS IMPORTANT TO NOTE THAT DURING MFG, EACH STAND AND STAND CONTROL CABINET HAVE THE SAME SERIAL NUMBER AND ARE TESTED THEN SHIPPED TOGETHER. IN THIS SITUATION, THE NEW STAND AND THE ORIGINAL CONTROL CABINET WERE NOT COMPATABLE. THEREFORE, THE WIRING SCHEMATICS SUPPLIED WITH THE ORIGINAL SYS WERE NO LONGER RELEVANT FOR THE NEW SYS. THE BRAKE WAS NOT WIRED PROPERLY FROM THE CONTROL CABINET AND THIS WIRING ERROR PREVENTED THE BRAKE FROM ENGAGING WHEN THE SYS LOST POWER FOR ANY REASON, SUCH AS ACTIVATION OF THE EMERGENCY STOP. ADDITIONALLY, THE WIRING FOR THE MOTOR POWER WAS IMPROPERLY CONNECTED LEADING TO INTERMITTENT MOTOR FAILURE. THESE TWO WIRING ERRORS LED TO AN UNSAFE SITUATION. THIS ERROR HAS BEEN COMMUNICATED TO THE DEALER/SVC PROVIDER AND IS CONSIDERED BY ALL CONCERNED TO BE EXTREMELY UNLIKELY TO RECUR. NOTE: THE SYS WAS REPLACED BY XPLORER 2200 SYS. DURING AN INVESTIGATION BY THE MFR, IT WAS DETERMINED THAT ALL MALFUNCTIONS WERE DUE TO INSTALLATION ERRORS. A SUBSEQUENT MALFUNCTION WAS DUE TO A WIRING ERROR MADE BY THE SVC ORGANIZATION. THE ROOT CAUSE OF THE INITIAL PROBLEM TURNED OUT TO BE A WIRING DIFFERENCE BETWEEN THE ORIGINAL TUBE STAND AND A REPLACEMENT TUBE STAND. THE CUSTOMER HAD ORDERED A REPLACEMENT SYS WHICH INCLUDED THE LONGER CABLES DESIRED BY THE CUSTOMER. IN A SYS, TUBE STANDS ARE MATCHED WITH THEIR CONTROL CABINETS AND ARE TESTED TOGETHER. WHEN THE REPLACEMENT SYS ARRIVED, THE SVC ORGANIZATION CHANGED ONLY THE TUBE STAND, AND NOT THE CONTROL CABINET. THIS CREATED A INCOMPATIBILITY WHICH CAUSED THE BRAKE FAILURE. THE TUBE STAND AND CONTROL CABINET SHOULD BOTH HAVE BEEN REPLACED TOGETHER. A THIRD MALFUNCTION OCCURRED WHICH WAS CAUSED BY A POORLY CRIMPED CONNECTION MADE BY THE SVC ORGANIZATION. CONCLUSION: ALL FAILURES WERE CAUSED BY FAULTY INSTALLATION(S), NOT BY DEFECTIVE EQUIPMENT.

    Description of Event or Problem · 1

    AN IMAGING DYNAMICS COMPANY (IDC) XPLORER 1600 DIGITAL RADIOGRAPHIC SYS WAS IN USE AT (B)(6) HOSP. THE SYS WAS BEING POSITIONED FOR A SEATED AP CHEST EXAM AND THE ARM FELL OR MOVED DOWNWARD SO RAPIDLY AS TO GIVE THE APPEARANCE OF FALLING FREELY. THE DROP WAS APPROX 22 CM. THE SYS CAME TO A STOP WITH THE IDC XPLORER 1000 DETECTOR HEAD RESTING ON THE MATTRESS OF A MOBILE HOSP BED. THE PT HAD BEEN SEATED ON THE BED AT THE TIME OF THE INCIDENT WITH HER BACK TO THE DETECTOR HEAD, SO SHE WAS NOT AFFECTED IN ANY WAY OTHER THAN THE ADD'L TIME FOR STAFF TO REMOVE HER FROM THE ROOM AND PERFORM HER CHEST EXAM ELSEWHERE. THERE WAS NO INJURY TO ANY HEALTH PROFESSIONAL. THERE WAS NO ACCIDENTAL RADIATION EXPOSURE. (B)(6) SUBMITTED THE ATTACHED MDR TO FDA ON (B)(6) 2006. HOWEVER, IMAGING DYNAMICS COMPANY (IDC) COULD NOT VERIFY THEIR SUBMISSION AND DECIDED TO SEND THIS REPORT AFTER DISCUSSION WITH FDA INSPECTOR WHO INSPECTED IMAGING DYNAMICS COMPANY IN (B)(6) 2006. DUE TO THIS REASON, THIS ANCILLARY 3RD PARTY REPORT IS NOT MEETING THE 30- DAY INITIAL REPORTING REQUIREMENTS. THIS WAS A MALFUNCTION OF A DIAGNOSTIC X-RAY SYS WITH A MOTORIZED "C-ARM" STRUCTURE. A RADIOLOGY TECH WAS PREPARING THE DEVICE FOR AN X-RAY PROCEDURE AND WHILE LOWERING THE C-ARM PORTION OF THE STAND, THE UNIT LOST POWER CAUSING THE "C-ARM" TO MOVE DOWNWARDS IN AN UNCONTROLLED STATE AND IT STOPPED WHEN IT HIT A GURNEY TABLE. AFTER THIS HAPPENED, THE SYS COULD NOT BE MOVED VERTICALLY UPWARDS SO THE LOCAL SVC COMPANY WAS CALLED TO INVESTIGATE THE PROBLEM. THIS PROBLEM RECURRED TWICE SUBSEQUENTLY, ONCE DURING SERVICING AND ONCE PRIOR TO A PROCEDURE. IN ALL CASES, THERE WERE NO PTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPLORER 1600 WITH SEDECAL X PLUS LP STAND DIGITAL X-RAY IMAGING SYSTEM KPR SEDECAL SA URS PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1