BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 3911186 · Received July 2, 2014

    Report

    Report Number
    1723170-2014-00716
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION HAS NOT BEEN PROVIDED. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE DOOR WINCH AND ROTOR TRACTOR DRIVE SHOWED A MECHANICAL FAILURE. THE REPORTED EVENT WAS CONFIRMED. THE CAUSE WAS THAT THE CUSTOMER PERFORMED THE MECHANICAL DOOR OPEN PROCEDURE INCORRECTLY AND DAMAGED THE PLASTIC TAG ON THE PIN. THE PARTS WERE REPLACED AND THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL.

    Additional Manufacturer Narrative · 1

    TWO COMPONENTS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE WINCH ASSEMBLY WAS TESTED ON THE MOTION CART, AND WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE DRIVE ASSEMBLY SHOWED SIGNS OF PHYSICAL DAMAGE. THE BELT TEETH HAD BEEN SLID OVER. THE MOST LIKELY CAUSE WAS THAT THE CUSTOMER PERFORMED MECHANICAL DOOR OPEN PROCEDURE INCORRECTLY DAMAGING THE DEVICE. THE REPORTED EVENT WAS CONFIRMED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THE IMAGING SYSTEM DOOR WOULD NOT OPEN AFTER BEING PLACED AROUND PATIENT FOR SPINE PROCEDURE. THE IMAGE ACQUISITION SYSTEM (IAS) POWERED OFF SEVERAL TIMES AND WOULD NOT REMAIN POWERED ON LONG ENOUGH TO USE ANY OVERRIDE FUNCTIONS ON THE PENDANT. THE SITE WAS UNABLE TO PLACE THE T-PIN TO BEGIN MANUAL DOOR OPEN PROCESS. AFTER PATIENT INCISION, THERE WAS ABOUT A 1 HOUR DELAY TO THE PROCEDURE IN ORDER TO REMOVE THE IMAGING SYSTEM. THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY WITHOUT THE USE OF AN IMAGING SYSTEM. THERE WAS NO REPORTED IMPACT TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385996 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