BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5454911 · Received February 23, 2016

    Report

    Report Number
    1723170-2016-00243
    Event Type
    Malfunction
    Date Received
    February 23, 2016
    Date of Event
    January 26, 2016
    Report Date
    April 11, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOW PROVIDED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT MADE AVAILABLE FROM THE SITE. ON (B)(6) 2016 A MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. ACTION: UPON ARRIVAL, IMAGE ACQUISITION SYSTEM (IAS) WOULD NOT BOOT COMPLETELY AS STATED IN THE COMPLAINT. "INITIALIZING SYSTEMS PLEASE WAIT" WAS DISPLAYED ON THE PENDANT, WITH GREEN BARS ONLY PRESENT FOR MOTION STATUS INDICATOR. REMOTE DESKTOP SHOWED "READY" IN THE MOTION COLUMN, HOWEVER, THERE WAS NO DATA PRESENT FOR THE INDIVIDUAL CONTROLLERS. REMOVED GENERATOR COVERS/BELLOWS COVER. TESTED VOLTAGES ON MOTION RELAY, AND DISCOVERED 24 VDC MISSING WHEN POWER ON SEQUENCE WAS INITIATED. REPLACED 200 VDC MOTION RELAY/VARISTOR. AFTER REPAIR, IMAGING SYSTEM BOOTS NORMALLY WITH MOTIONS PRESENT. SYSTEM CHECKOUT PERFORMED WITH SATISFACTORY RESULTS. ISSUE RESOLVED. RETURN REQUESTED. REPLACEMENT VARISTOR OXID 20MM 200VDC SHIPPED TO SITE 01/27/2016. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT VARISTOR OXID 20MM 200VDC FINDS NO PROBLEM WITH THE VARISTOR. THE PROBLEM WAS FOUND WITH THE RELAY. TEST RESULTS HAVE BEEN UPLOADED TO DOCUMENT WHERE THE VARISTOR WAS TESTED AT THE SAME TIME AS THE RELAY. ON 01/27/2016 RETURN REQUESTED FOR SUSPECT RELAY. MEDTRONIC INVESTIGATION OF SUSPECT RELAY, RETURNED ON 02/18/2016, CONFIRMS THAT OUTPUT PINS 1 AND 2 HAVE A LOW RESISTANCE SHORT OF 8.3 OHMS INTERNALLY. RELAY IS DEFECTIVE. ELECTRICAL FAILURE - DEFECTIVE RELAY. ON 02/10/2016 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THE PROCEDURE WAS POSTPONED UNTIL LATER ON IN THE SAME DAY, AFTER NECESSARY REPAIRS TO THE IMAGING SYSTEM WERE COMPLETED. THE SURGEON MADE THIS DECISION PRIOR TO INCISION. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A SITE RADIOLOGY REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SITE'S IMAGING SYSTEM WOULD NOT FULLY BOOT AND WAS GETTING STUCK ON "SYSTEM INITIALIZING, PLEASE WAIT" MESSAGE. THE SITE REPRESENTATIVE ATTEMPTED TO RE-BOOT THE IMAGING SYSTEM BY UNPLUGGING THE UMBILICAL CABLE, RE-BOOTING BOTH THE MOBILE VIEWING SYSTEM (MVS) AND IMAGE ACQUISITION SYSTEM (IAS), AND THEN RE-PLUGGING THE UMBILICAL CABLE, HOWEVER, THE ISSUE PERSISTED. THE MVS AND FLOURO STATUS HAD GREEN CHECK MARKS, BUT THE MOTION STATUS WAS FIXED LOADING. THE GANTRY COULD NOT BE MOVED. USE OF THE IMAGING SYSTEM AND THE NAVIGATION SYSTEM WERE DISCONTINUED. THE SURGEON OPTED TO ABANDON THE PROCEDURE, THIS WAS AFTER ANESTHESIA, AND BEFORE INCISION. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110907 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 72 YR