BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 11008982 · Received December 15, 2020

    Report

    Report Number
    3004785967-2020-01497
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 14, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: B I71000165, SERIAL/LOT #: NONE. INTERNAL ANALYSIS/TROUBLESHOOTING WAS DONE. IT WAS DISCOVERED THAT THE COMPUTER WAS NOT THE PROBLEM AS ORIGINALLY THOUGHT. IT WAS FOUND THAT THE CMOS BATTERY NEEDED TO BE REPLACED. THE SYSTEM WAS SERVICED IN THE FIELD AND FAILED IMAGING TESTS DUE TO THE IAS NOT INITIALIZING. THE CMOS BATTERY WAS REPLACED ON THE IAS COMPUTER AND THE BIOS SETTINGS WERE PROGRAMMED. THE FAILURE WAS RESOLVED AND THE SYSTEM WAS OPERATIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE IMAGE ACQUISITION STATION (IAS) WOULD NOT FULLY INITIALIZE. THEY TRIED REBOOTING THE SYSTEM. NO PATIENT WAS PRESENT. IT WAS REPORTED THAT THE SYSTEM NEEDED A COMPUTER FOR THE IAS. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) BATTERY WAS COMPLETELY DEAD SO WHEN THE SITE REBOOTED THE SYSTEM, THE IAS REMAINED IN THE INITIALIZING STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477935 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC (LITTLETON) 9732719

    Patients

    Seq Age Sex Outcome Treatment
    1