BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 5982178 · Received September 27, 2016

    Report

    Report Number
    1723170-2016-02406
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    August 30, 2016
    Report Date
    January 18, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K151000
    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 FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND CONFIRMED THE MVS WOULD NOT TURN ON. ON (B)(6) - DIN RAIL FUSES BLEW. REPLACED FUSES AND SYSTEM IS FULLY FUNCTIONAL. DIN RAIL UPGRADE ORDERED. ON 9/2 - DIN RAIL UPGRADED. FULL CHECKOUT PERFORMED. SYSTEM IS FULLY FUNCTIONAL.

    Additional Manufacturer Narrative · 1

    THE DIN RAIL ASSEMBLY WITH FUSES WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. TWO FUSES WERE RETURNED. BOTH FUSES, 15A/ 250V, WERE GOOD. BEFORE APPLYING (B)(4) BETWEEN CONTACTS 7 AND 10, 12.4 OHMS WAS MEASURED AS EXPECTED ON THE DIN RAIL ASSEMBLY. THE TESTER ENERGIZED THE ASSEMBLY, THERE WAS AN AUDIBLE CLICK AS THE RELAY CLOSED BETWEEN CONTACTS 7 AND 10, 0.02 OHMS WAS MEASURED AS EXPECTED. THE DIN RAIL ASSEMBLY WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED ON THE DIN RAIL BY MEDTRONIC PERSONNEL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION SURGERY, THE SITE'S O2 SYSTEM'S MVS (MOBILE VIEWING STATION) WOULD NOT BOOT. REP WAS ON SITE AND DETERMINED THE FUSES WERE BLOWN. THE SITE USED THEIR O-ARM 1ST GENERATION SYSTEM TO CONTINUE THE CASE WITH NO IMPACT TO PATIENT OUTCOME AND MINIMAL DELAY UNDER AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630986 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON)

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR