BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 4103451 · Received September 19, 2014

    Report

    Report Number
    1723170-2014-01001
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 21, 2014
    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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. (B)(4) 2014 REPLACEMENT ATP CONSOLE SHIPPED TO SITE. DEVICE WAS RETURNED TO MANUFACTURER ON (B)(4) 2014, UNUSED. - RMA ISSUED. REPLACEMENT MOTION CONTROL BOX SHIPPED TO SITE (B)(4) 2014. SUSPECT MOTION CONTROL BOX RETURNED TO MANUFACTURER (B)(4) 2014 AND IS UNDER ANALYSIS. - (B)(4) 2014 A MEDTRONIC REPRESENTATIVE PERFORMED A IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. ISSUE COULD NOT BE REPLICATED. - A MEDTRONIC INVESTIGATOR FOUND THE CAUSE OF THE O-ARM 1000 IMAGING SYSTEM NOT MOVING IN X-AXIS WAS DUE TO THE X-CAGE CARRIAGE HAVING BEEN BROKEN AND HAD DISLODGED INTO THE DRIVE. - THE MANUFACTURING INVESTIGATION ON THE BROKEN X-DRIVE ASSEMBLY CONCLUDED THIS SYSTEM APPEARS TO HAVE BEEN DAMAGED PREVIOUSLY, NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE IDENTIFIED. - THE SYSTEM WAS REPAIRED AT MEDTRONIC, INC., (B)(4), BEFORE BEING RETURNED TO THE FIELD. MALFUNCTION WAS CAUSED BY THE PREVIOUS DAMAGE TO THE SYSTEM.

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REPORT WAS THAT THE X-DRIVE CARRIAGE BECAME DAMAGED, WHICH COULD LEAD TO THE INABILITY TO STOP THE MOTION OF THE GANTRY. ENGINEERING EVALUATION FOUND THAT THE ROOT CAUSE OF THE REPORTED ISSUE WAS THAT THIS SYSTEM WAS DROPPED DURING UNLOADING AT A SITE. THIS IS A DEMO SYSTEM, WHICH IS MOVED FROM SITE TO SITE. THE DAMAGE TO THE X-DRIVE OCCURRED WHEN THE SYSTEM WAS DROPPED, BUT WAS NOT DETECTABLE UNTIL 08/21/2014, WHEN THE FIELD SERVICE ENGINEER WAS CHECKING THE SYSTEM FOR AN ALLEGATION THAT THE GANTRY COULD NOT BE MOVED OUT IN THE X DIRECTION. A FIELD SERVICE ENGINEER REPLACED THE X DRIVE BALL SCREW ASSEMBLY AND THE POSITION MOTION CONTROLLER. ANALYSIS OF THE ORIGINAL MOTION CONTROLLER WHICH WAS INSTALLED AT THE TIME OF THE REPORTED EVENT IS AS FOLLOWS: WAG MOTION DID NOT WORK. TORQUE GOES TO -13000. ANALYSIS OF THE X STAGE BALL SCREW ASSEMBLY FOUND THAT ONE JACK SCREW WAS BROKEN. PHYSICAL DAMAGE DUE OCCURRED DUE TO AN UNUSUAL EVENT WHERE THE SYSTEM WAS DROPPED DURING INSTALL. THE O-ARM HAS BEEN REPAIRED BY THE MANUFACTURER AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN O-ARM 1000 IMAGING SYSTEM THAT WAS UNABLE TO BOOT-UP PROPERLY. THE O-ARM PENDANT DISPLAYED GREEN CHECKMARKS FOR THE MOTION AND COMPUTER, HOWEVER, THE X-RAY WAS NOT CONNECTING. IN TROUBLE-SHOOTING, RE-BOOTING THE O-ARM DID NOT RESOLVE THE ISSUE. ALL POSITIONER MOTION CONTROLLER CABLES WERE CHECKED AND FOUND TO BE SEATED TIGHTLY. MEDTRONIC REPRESENTATIVE, FOLLOWING-UP, NOTED THAT THE O-ARM GANTRY WAS UNABLE TO BE MOVED OUT IN X-AXIS, HOWEVER, WAS SUCCESSFULLY ABLE TO MOVE IN Y-AXIS AND Z-AXIS, UP/DOWN AND LEFT/RIGHT. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584072 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