BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORT300 OPERATING ROOM TABLE

    MDR report key: 6687124 · Received July 5, 2017

    Report

    Report Number
    3010326005-2017-00003
    Event Type
    Injury
    Date Received
    July 5, 2017
    Date of Event
    April 3, 2017
    Report Date
    October 20, 2017
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    PMA / PMN Number
    K083137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT. A SUMMARY OF THE ROOT CAUSE ANALYSIS FOLLOWS. THE ORT300 TABLE WAS EVALUATED UPON RETURN. INCLUDED WAS A PICTURE OF AN OIL LEAK AND A VIDEO FROM THE HOSPITAL. THE VIDEO SHOWS IRREGULAR MOTION WHEN THE TABLE IS ACTUATED. THE LIFT CYLINDER APPEARS TO BE ACTUATED. THE TABLE LIFTS AS EXPECTED, HOWEVER, WHEN THE ACTUATION IS COMPLETED, THE TABLE APPEARS TO RELAX TO A LOWER POSITION (DROPS IN ELEVATION). BASED ON THE VIDEO, INITIAL JUDGEMENT TO EXPLAIN THE ISSUE IS AIR TRAPPED IN THE HYDRAULIC SYSTEM. THIS WOULD CAUSE A MOMENTARY INSTABILITY OF THE TABLE TOP POSITION UNTIL THE AIR BLEEDS OVER THE HYDRAULIC CYLINDER SEAL UNTIL THE CYLINDER PISTON IS SUPPORTED BY THE HYDRAULIC OIL. AN INCREASED PROBABILITY OF TRAPPED AIR IN THE HYDRAULIC SYSTEM IS LIKELY SINCE THE TABLE HAD RECENTLY UNDERGONE A FIELD REPAIR THAT REPLACED TWO HYDRAULIC CYLINDERS. IT APPEARS THAT THE FIELD ENGINEER DID NOT COMPLETELY BLEED THE AIR OUT OF THE SYSTEM. WHEN THE TABLE WAS RETURNED, THE BEHAVIOR IN THE VIDEO COULD NOT BE DUPLICATED. IT WAS CONCLUDED THAT ANY AIR TRAPPED IN THE HYDRAULIC SYSTEM WORKED ITS WAY OUT OF THE SYSTEM PRIOR TO RETURN FROM THE CUSTOMER. IN ADDITION, A SMALL OIL LEAK WAS IDENTIFIED ON THE LOWER FITTINGS OF THE TRENDELENBURG CYLINDER. A SMALL DRIFT WAS PRESENT IN THE TRENDELENBURG MOTION THAT APPEARS TO CORRESPOND WITH THE LEAK. THE DRIFT RATE OF THE TABLE WAS TESTED MULTIPLE TIMES AND TESTED WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 0

    THIS IS A 2ND FOLLOW-UP REPORT FOR THE TWO INCIDENTS AT (B)(6) HOSPITAL (REPORT #S 3010326005-2017-00003 AND 3010326005-2017-00006). THE FOLLOWING CORRECTIVE ACTIONS WERE PUT IN PLACE AS A RESULT OF THESE TWO INCIDENTS: STE. JUSTINE WAS NOTIFIED TO NOT USE THE ORT300 TABLE UNTIL THE IMRIS CUSTOMER SERVICE FIELD ENGINEER INSPECTED THE TABLE AND INVESTIGATED THE ISSUE. THE LIFT AND TRENDELENBERG CYLINDERS ON THE OR TABLE WERE REPLACED AND PROPER FUNCTION OF THE TABLE WAS VERIFIED. STE. JUSTINE WAS ALLOWED TO USE THE TABLE AGAIN. AN INTERNAL CAPA (I17-00-003) WAS ISSUED TO INVESTIGATE THE ISSUE AND DETERMINE ROOT CAUSE(S). THE TRENDELENBERG CYLINDER THAT HAD EXHIBITED A SMALL HYDRAULIC FLUID LEAK WAS RETURNED TO THE VENDOR FOR FURTHER ROOT CAUSE ANALYSIS. NO DISCREPANCIES WERE OBSERVED BY THE VENDOR. A 2ND INCIDENT OCCURRED AND THE TABLE WAS REPLACED WITH A NEW TABLE. INVESTIGATION OF THE RETURNED TABLE SHOWED THAT THE DRIFT WAS MOST LIKELY CAUSED BY TRAPPED AIR IN THE TABLE HYDRAULIC SYSTEM THAT WAS NOT PROPERLY BLED OUT WHEN THE TREND AND LIFT CYLINDERS WERE REPLACED. FURTHER ROOT CAUSE ANALYSIS WAS PERFORMED. THE FILTER THAT IS USED IN THE ORT300 HYDRAULIC KIT WAS FOUND TO BE DIFFERENT THAN THE FILTER USED IN OTHER TABLES - THE OPENINGS WERE LARGER, MEANING THAT CONTAMINANTS INTRODUCED INTO THE HYDRAULIC SYSTEM WERE NOT PROPERLY FILTERED OUT. THE INCORRECT FILTER OCCURRED AS A RESULT OF A DRAWING ERROR AND WAS CORRECTED VIA ENGINEERING CHANGE ORDER. THE PRODUCTION OR TABLE WORK INSTRUCTIONS WERE UPDATED WITH HYDRAULIC FITTING INSTALLATION INSTRUCTIONS, VERIFICATION OF THE RUPTURE PROTECTION VALVE DURING ASSEMBLY, AND AN AIR BLEEDING PROCEDURE. OR TABLE PREVENTIVE MAINTENANCE MANUALS WERE ALSO UPDATED BY CONSOLIDATING THE AIR BLEEDING PROCEDURES BETWEEN PRODUCTION AND FIELD SERVICE.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP REPORT ON TWO INCIDENTS THAT OCCURRED AT STE. JUSTINE HOSPITAL WHERE TWO PATIENTS EXPERIENCED EXCESSIVE BLEEDING AS A RESULT OF THE ORT300 TABLE DRIFTING HEAD DOWNWARDS DURING THE PROCEDURES. THE FIRST INCIDENT OCCURRED ON (B)(6) 2017 WITH THE 2ND INCIDENT OCCURRING ON (B)(6) 2017 (REPORT #S 3010326005-2017-00003 AND 3010326005-2017-00006. THE FIRST PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A RESULT OF CEREBRAL SPINAL FLUID LEAKS THAT REQUIRED REPAIR; THERE WERE NO ADDITIONAL PHYSIOLOGICAL CONSEQUENCES EXPERIENCED BY THE SECOND PATIENT.

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF TRENDING ANALYSIS OF CUSTOMER COMPLAINTS AND SERVICE CALLS, THIS INCIDENT APPEARS TO BE AN ISOLATED INCIDENT. THE DEVICE HISTORY RECORD FOR THE OR TABLE WAS REVIEWED AND NO DISCREPANCIES WERE OBSERVED. THE FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE TO INSPECT THE TABLE AND PERFORM FURTHER INVESTIGATION INTO THE ROOT CAUSE. THE ISSUE OF DRIFT WAS VERIFIED IN THE TRENDELENBURG CYLINDER. A REPLACEMENT TREND CYLINDER WAS INSTALLED. THE TABLE WAS FUNCTIONALLY TESTED TO VERIFY PROPER OPERATION, INCLUDING A 10 HOUR OVERNIGHT DRIFT TEST WITH 25 KG PLACED AT THE END OF THE BACK SECTION. THE DRIFT TEST RESULT PASSED WITH 0.0 DEGREES OF DRIFT. THE TRENDELENBURG CYLINDER IS BEING RETURNED TO IMRIS AND WILL SUBSEQUENTLY BE SHIPPED TO THE VENDOR FOR FURTHER ROOT CAUSE INVESTIGATION.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE FOR CEREBRAL ARTERIAL VENUS MALFORMATION (AVM) ON (B)(6) 2017, THE CHIEF NURSE AND THE SURGEONS NOTICED THAT THE PATIENT WAS BLEEDING EXCESSIVELY AND INTRACRANIAL PRESSURE HAD DROPPED. THE SURGEONS ELECTED TO NOT PERFORM INTRA-OPERATIVE IMAGING DUE TO THE SWOLLEN CEREBELLUM. THEY CLOSED THE SKIN QUICKLY WITHOUT PROPERLY CLOSING THE SKULL AND THE DURA MATER. AS THEY WERE PREPARING THE ROOM FOR POST-OP IMAGING AFTER THE CASE, THEY OBSERVED THAT THE OR TABLE WAS TILTED HEAD DOWNWARD. POST-SURGERY (AT HOME), THE CHILD HAD A CEREBRAL SPINAL FLUID LEAK AND RETURNED TO THE HOSPITAL FOR A PROLONGED STAY. THE CEREBRAL SPINAL FLUID LEAK RECURRED TWO MORE TIMES BECAUSE THE DURA MATER AND NOT BEEN CLOSED. THE LEAKS WERE REPAIRED WITH STITCHES ON BOTH OCCURRENCES. ON (B)(6) 2017, THE PATIENT UNDERWENT A SECOND OPERATION TO CLOSE THE DURA MATER, SKULL AND SKIN. THE SURGERY WENT WELL ACCORDING TO THE OR STAFF. THE IMPACT ON THE PATIENT'S NEUROLOGICAL FUNCTIONS ARE UNDETERMINABLE AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468157 ORT300 OPERATING ROOM TABLE RADIOLOGIC TABLE, PRODUCT CODE KXJ KXJ IMRIS - DEERFIELD IMAGING, INC. ORT300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Male Required Intervention| H| L