BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 3113695 · Received May 15, 2013

    Report

    Report Number
    1723170-2013-00130
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT AVAILABLE FROM THE SITE. ADDITIONAL EVENT DESCRIPTION PROVIDED. THE FOLLOWING ADDITIONAL INVESTIGATION WAS PROVIDED ON A FDA 45DAY RESPONSE LETTER SUBMITTED ON (B)(4) 2013: ON (B)(4) 2013, A MEDTRONIC FIELD SERVICE ENGINEER (FSE) CONDUCTED AN ONSITE INVESTIGATION OF THE REPORTED ISSUE. THE FSE REPLACED THE STANDALONE BOARD AND RELAY COMPONENTS OF THE IMAGING SYSTEM, AFTER WHICH, A SYSTEM CHECKOUT SHOWED THAT THE DEVICE WAS FULLY FUNCTIONAL. A HAZARD REPORT INCLUDING A REVIEW OF THE COMPLAINT HISTORY, PRE- AND POST-MITIGATION RISK ASSESSMENT, AND CALCULATION OF PROBABILITY OF OCCURRENCE OF HARM WAS COMPLETED. THE SPECIFIC FAILURE MODE WAS AN ELECTRICAL FAILURE MODE. THE ASSOCIATED COMPONENTS WERE DIODE (D3), TRANSISTOR (Q11), RESISTORS (R21/R20) AND CAPACITOR (C13) ON THE STANDALONE BOARD (P/N BI-310-00171, S/N (B)(4)). MEDTRONIC INVESTIGATION OF THE RETURNED DEVICE CONFIRMED THAT THE FOLLOWING COMPONENTS WERE OVERHEATED/BURNED ON THE STANDALONE BOARD: Q11, R21, R20 AND C13. D3 WAS ALSO SHORTED (MEASURED AT 29 OHMS). THE BURNED AREA WAS LIMITED TO A SMALL SECTION CONTAINING THE FAILED COMPONENTS. THE RELAY INPUT WAS SHORT BETWEEN PIN 1 AND 2 (MEASURED AT 0.1 OHM). THE ROOT CAUSE WAS AN ELECTRICAL SHORT ON THE STANDALONE BOARD. AS A RESULT OF THE INVESTIGATION PERFORMED, THE FAILURE MODE WAS IDENTIFIED AND THE ROOT CAUSE WAS DETERMINED TO BE THE UNDERRATED VOLTAGE (90V RATING) OF THE D3/D5 DIODES ON THE STANDALONE BOARD FOR REV M OR EARLIER. AN ENGINEERING CHANGE ORDER ADDRESSED THIS ISSUE BY UPGRADING THE VOLTAGE OF DIODES D3/D5 TO A RATING OF 200V. THIS FAILURE WAS ON A STANDALONE BOARD MANUFACTURED PRIOR TO THE ECO IMPLEMENTATION. PER THE HAZARD REPORT, THE SEVERITY AND PROBABILITY OF HARM WERE REVIEWED, AND THE RESIDUAL RISK WAS FOUND TO BE ACCEPTABLE. THE HAZARD REPORT IDENTIFIED THE FOLLOWING SAFETY MITIGATIONS: 1) SOURCES FOR ELECTRICAL COMPONENT FAILURE OR WIRING SHORT CAUSING OVER-HEATING, OPEN FLAME, SMOKE, OR TOXIC FUMES ARE ENCASED AND NOT EXPOSED TO THE PATIENT. 2) INSTEAD OF THE PATIENT, THE FIELD SERVICE PERSON WOULD BE AT THE HIGHEST RISK WHEN SERVICING THE SYSTEM WITH THE COVERS OFF 3) IF A SAFETY EVENT HAPPENS WHILE A FIELD SERVICE PERSON HAS THE COVERS OFF DURING SERVICING, THEY ARE TRAINED TO DISCONNECT J7 TO ELIMINATE ELECTRICAL POWER TO THE SYSTEM 4) IEC 60601-1 2ND EDITION, REQUIRES DESIGNS TO USE MATERIALS THAT ARE FIRE SUPPRESSANT AND SELF-EXTINGUISHING 5) USER MANUAL, BI-500-00142, SECTION 1, PAGE 14 HAS A WARNING "DO NOT REMOVE CABINET COVERS. CERTAIN ELECTRICAL CIRCUITS INSIDE THE EQUIPMENT USE DANGEROUSLY HIGH VOLTAGES. FAILURE TO HEED THIS WARNING COULD RESULT IN SERIOUS INJURY OR DEATH." 6) USER MANUAL, BI-500-00142, SECTION 1, PAGE 17, HAS A CONTRA-INDICATION WARNING: "DO NOT USE O-ARM IMAGING SYSTEM IN THE PRESENCE OF FLAMMABLE OR EXPLOSIVE GASES, LIQUIDS, OR ANESTHETICS." 7) IF OXYGEN IS USED DURING A PROCEDURE, THE OXYGEN IS PLUMBED DIRECTLY TO THE PATIENTS' NOSTRILS/MOUTH AND IS NOT AN OPEN SOURCE SATURATING THE OPERATING ROOM AIR. THE PROBABILITY OF OCCURRENCE OF HARM (P1P2) WAS COMPUTED TO BE 7.895 X 10-8 MULTIPLYING P1 (7.895E-5) BY P2 (0.001) WHICH RESULTED IN A RESIDUAL PROBABILITY OF OCCURRENCE OF HARM RANKING OF "IMPROBABLE." THE HAZARD REPORT CONCLUDED THAT THE OVERALL RESIDUAL RISK WAS "ACCEPTABLE" AND THEREFORE NO FURTHER ACTION WAS REQUIRED.

    Additional Manufacturer Narrative · 1

    DUE TO FIELD CHARACTER LIMITATIONS THE COMPLETE PATIENT ID IS (B)(6). PATIENT WEIGHT WAS UNKNOWN. (B)(4). RMA ISSUED AND A MEDTRONIC REPRESENTATIVE REPLACED STANDALONE BOARD AND RELAY ON (B)(4) 2013. FOLLOWING REPLACEMENT OF SUSPECT DEVICE, AND COMPLETION OF O-ARM SYSTEM CHECK-OUT THE O-ARM SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE CONFIRMED COMPONENTS OVERHEATED/BURNED ON THE ISA BOARD. THE BURNED AREA WAS LIMITED TO A SMALL SECTION CONTAINING THE FAILED COMPONENTS. THE RELAY INPUT WAS SHORT BETWEEN PIN 1 AND 2. THE ISSUE WAS ABLE TO BE DUPLICATED AND FOUND TO HAVE DIRECTLY CAUSED THE EVENT. ALTHOUGH NO ONE WAS INJURED, SUCH A FAILURE MODE COULD POTENTIALLY CAUSE BURNING TO THE PATIENT OR USER.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN ISSUE USING AN O-ARM 1000 IMAGING SYSTEM THAT OCCURRED AT THE END OF A SPINE PROCEDURE. DURING A POST-OPERATIVE 3D ACQUISITION, THE SURGICAL TEAM MOVED THE SYSTEM AROUND THE PATIENT, CLOSED THE GANTRY, UNSUCCESSFULLY ATTEMPTED TO ADJUST THE ORIENTATION IN 3D MODE (BOTH TYPICAL STEPS DESCRIBED IN THE O-ARM USER MANUAL), AND WHEN THEY PRESSED THE 3D BUTTON A FLASH/SPARK OCCURRED FOLLOWED BY SMOKE. THE SITE IMMEDIATELY OPENED THE GANTRY, SEPARATED THE PATIENT FROM THE O-ARM, MOVED THE SYSTEM UP AGAINST THE WALL, AND THEN THE SYSTEM SHUT ITSELF DOWN. THE SYSTEM WAS FUNCTIONAL UNTIL THE POINT OF TAKING THE 3D ACQUISITION. NO PATIENT, OR STAFF MEMBER, EXPERIENCED ANY SORT OF INJURY OR IMPAIRMENT FROM THIS OCCURRENCE. AFTER THE INCIDENT, THE SURGEON DISCONTINUED IMAGING AND COMPLETED THE PROCEDURE WITH NO INJURY OR COMPLICATION TO THE PATIENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A HARDWARE ISSUE, AT THE END OF A SPINE PROCEDURE USING AN O-ARM 1000 IMAGING SYSTEM. DURING A POST-OPERATIVE SPIN, THERE WAS A BRIGHT FLASH FOLLOWED BY AN ELECTRICAL BURNING SMELL. NO PATIENT, OR STAFF MEMBER, WAS AFFECTED BY THIS OCCURRENCE. PRIOR TO THIS OCCURRING, THE SITE UNSUCCESSFULLY ATTEMPTED TO ADJUST THE ORIENTATION IN 3D MODE. THE SURGEON DISCONTINUED IMAGING AND COMPLETED THE PROCEDURE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214443 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00027-120

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR