BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 7561174 · Received June 1, 2018

    Report

    Report Number
    1723170-2018-02384
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    May 4, 2018
    Report Date
    July 30, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: UNIQUE DEVICE IDENTIFICATION (UDI) AND DEVICE MANUFACTURE DATE PROVIDED.

    Additional Manufacturer Narrative · 1

    UNIQUE DEVICE IDENTIFICATION (UDI) IS UNAVAILABLE. THE SUSPECT CABLE DOOR ASSEMBLY WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, RESULTS ARE NOT AVAILABLE AT THIS TIME. DEVICE MANUFACTURING DATE IS UNAVAILABLE. A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS IDENTIFIED THE DOOR FAILED TO ACT PROPERLY. TESTING FOUND A DAMAGED DOOR CLOSED SWITCH. THE SIDE SWITCH WAS REPLACED, ALIGNED AND TESTED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL.

    Additional Manufacturer Narrative · 1

    THE CABLE DOOR ASSEMBLY WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. TESTING FOUND THAT THERE WAS AN INTERMITTENT CONNECTION AT THE 5 PIN MTE CONNECTOR.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT AS THE GANTRY DOOR WAS CLOSING AROUND THE PATIENT, THE DOOR WOULD STOP, BEGIN CLOSING, AND THEN STOP AGAIN. THE SITE ABORTED USE OF THE MEDTRONIC IMAGING SYSTEM AND USED THEIR OTHER MEDTRONIC IMAGING SYSTEM. THE SURGERY WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN AN HOUR. THERE WERE NO FURTHER REPORTED CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404319 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON)

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR