BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6149982 · Received December 6, 2016

    Report

    Report Number
    1723170-2016-05711
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    November 11, 2016
    Report Date
    March 1, 2017
    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

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS EVENT. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER. EVENT PROBLEM AND EVALUATION: MEDTRONIC REQUESTED THAT AN IMAGING SYSTEM CHECK-OUT BE COMPLETED AT THE SITE; STATUS IS PENDING.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHEN ATTEMPTING TO MOVE THE IMAGING SYSTEM, IT WOULD NOT ADVANCE PAST "INITIALIZING PLEASE WAIT.¿ THERE WAS A GREEN CHECK FOR MOTION, BUT A RED X FOR BOTH THE GENERATOR AND THE CONNECTION TO THE MOBILE VIEW STATION (MVS). MULTIPLE REBOOTS DID NOT RESOLVE THE ISSUE. THIS ISSUE WAS IDENTIFIED OUTSIDE OF SURGERY; NO PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799038 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