BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPLORER 1600 WITH SEDECAL X PLUS LP STAND

    MDR report key: 2171423 · Received November 27, 2006

    Report

    Report Number
    9616853-2006-00002
    Event Type
    Malfunction
    Date Received
    November 27, 2006
    Date of Event
    March 15, 2006
    Report Date
    November 24, 2006
    Manufacturer
    STAND MFG BY SEDECAL SYSTEM INTEGRATOR - IMAGING DYNAMICS CO. LTD.
    Product Code
    KPR
    PMA / PMN Number
    K012546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGING DYNAMICS CO (IDC) IS REPORTING THIS INCIDENT AS MFR AND SYSTEM INTEGRATOR OF THE X1600 DIGITAL RADIOGRAPHIC SYSTEM (COMPROMISING OF THE IDC XPLORER 1000 DETECTOR HEAD AND SEDECAL'S X PLUS LP RADIOLOGIC STAND). BASED ON THE PRELIMINARY INVESTIGATION BY IDC AND SEDECAL, AN INTERMEDIATE TECHNICAL SERVICE BULLETIN (TSB) WAS ISSUED ON (B)(6) 2006 TO ALL USERS OF XPLORER 1600 UNITS. THE FAULTY UNIT WAS SHIPPED TO (B)(6) FACILITY IN (B)(6) FOR FURTHER INVESTIGATION. THE ROOT CAUSE FOR THE PROBLEM WAS IDENTIFIED AS LOOSE REAR BEARINGS IN THE CARRIAGE ASSEMBLY ON THE STAND. THIS CAN CAUSE LATERAL PLAY OF THE COMPLETE ASSEMBLY AND UNDER SOME CIRCUMSTANCES CAN CAUSE THE EMERGENCY BRAKE NOT TO ACTIVATE WHEN NEEDED. ON (B)(6) 2006 A SECOND TSB WAS ISSUED TO ALL END USERS, DEALERS AND SERVICE TECHNICIANS TO INSPECT ALL UNITS AND ADJUST/REPAIR AS NECESSARY. THE IDC XPLORER 1600 SERVICE MANUAL WAS REVISED TO INCLUDE THIS CHECK AS A PERIODIC MAINTENANCE ACTIVITY. AS REQUESTED BY SEDECAL, A THIRD TECHNICAL SERVICE BULLETIN WAS ISSUED ON (B)(6) 2006 TO ADDRESS THE ERROR E06 FUNCTIONALITY CHECK. IDC'S INTERNAL CORRECTIVE ACTION (B)(4) WILL CONTINUE TO REMAIN OPEN UNTIL EFFECTIVENESS OF THE CORRECTIVE ACTION IS CONFIRMED. SEDECAL SUBMITTED THE ATTACHED MDR TO FDA ON (B)(6) 2006. HOWEVER, IMAGING DYNAMICS CO. COULD NOT VERIFY THEIR SUBMISSION AND DECIDED TO SEND THIS REPORT AFTER DISCUSSION WITH FDA INSPECTOR WHO INSPECTED IMAGING DYNAMICS CO IN (B)(6) 2006. DUE TO THIS REASON THIS ANCILLARY 3RD PARTY REPORT IS NOT MEETING THE 30- DAY INITIAL REPORTING REQUIREMENTS. ADD'L INFO FROM MFR REPORT #: 9617251-2006-00002: NO PT INJURY. IDC/SEDECAL. DIAGNOSTIC X-RAY SYSTEM. (B)(6). MODEL - XPLORER 1600. (B)(6). EVAL SUMMARY: THE PRELIMINARY INVESTIGATION REVEALED EXCESS "PLAY" IN ONE OF THE SUPPORT BEARINGS. THE UNIT HAS BEEN SHIPPED BACK TO THE MFR IN (B)(6) FOR FURTHER EVAL. AN UPDATE WILL BE PROVIDED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    AN IMAGING DYNAMICS COMPANY (IDC) XPLORER 1600 DIGITAL RADIOGRAPHIC SYSTEM WAS IN USE AT THE DIAGNOSTIC MEDICAL GROUP OF (B)(6). AT APPROX 2:30 PM, THE SYSTEM WAS BEING RE-POSITIONED FOR A STANDING KNEE EXAM. THE RADIOLOGY TECHNICIAN HEARD A LOUD NOISE AND THE SYSTEM STOPPED WITH AN ERROR CODE (E06). THE RADIOLOGY TECHNICIAN CONTACTED THE IDC AUTHORIZED SERVICE TECHNICIAN AND BASED ON HIS INSTRUCTIONS, THE POWER WAS RESET ASSUMING IT WAS AN ERROR CODE FOR THE GENERATOR. THE E06 ERROR CLEARED WHEN THE POWER WAS RESET. THE RADIOLOGY TECHNICIAN THEN REDUCED THE SOURCE TO IMAGE DISTANCE (SID) AND THE XPLORER 1600 SYSTEM C-ARM SUFFERED AN UNCONTROLLED CRASH TO THE FLOOR. THE SYSTEM WAS PUT "OUT OF ORDER" AND HELP WAS REQUESTED FROM THE SERVICE TECHNICIANS. NO PT WAS INVOLVED IN THIS EVENT. 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 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. A TEMPORARY RADIOLOGY TECHNICIAN WAS IN THE X-RAY ROOM AT THE TIME OF THE PROBLEM. THE X-RAY UNIT WAS IN POSITION FOR A 72" CHEST X-RAY, AND HE WAS STARTING TO BRING IT INTO POSITION TO DO A STANDING KNEE X-RAY. THE MOTION WAS ROUGH, AND HE ENCOUNTERED AN E06 ERROR CODE. ACCORDING TO THE TECHNICIAN, THERE WAS NO OBSTRUCTION TO THE MOVEMENT OF THE C-ARM. HE CALLED ON A MORE EXPERIENCED TECHNICIAN FOR ASSISTANCE. THEY RECYCLED POWER AND THE ERROR CODE CLEARED. AS THEY DROVE THE C-ARM DOWN, THE UNIT CRASHED FROM ABOUT 30 INCHES HEIGHT TO THE FLOOR. THE TECHNICIAN STATED THAT IT SEEMED TO HIM THAT THE UNIT WAS IN "FREE FALL" RATHER THAN A RAPID DRIVE DOWNWARD.

    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 STAND MFG BY SEDECAL SYSTEM INTEGRATOR - IMAGING DYNAMICS CO. LTD. A8117-10

    Patients

    Seq Age Sex Outcome Treatment
    1 NO PT INVOLVED.