BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 9413539 · Received December 4, 2019

    Report

    Report Number
    3004785967-2019-02077
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    November 26, 2019
    Report Date
    December 4, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: BI71000850R, SERIAL/LOT #: REV. 1 : S/N (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE IAS WAS NOT BOOTING. THE IAS COMPUTER WAS REPLACED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. DEVICE MANUFACTURING DATE UNAVAILABLE. 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. IT WAS REPORTED THE IMAGE ACQUISITION SYSTEM (IAS) WILL NOT BOOT AND SHOWED A MESSAGE STATING, ¿SYSTEM BOOTING, PLEASE WAIT¿. IT WAS NOTED REBOOTING THE SYSTEM DID NOT RESOLVE THE ISSUE. THIS ISSUE WAS NOTED OUTSIDE OF A PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203334 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC (LITTLETON) BI70000027120

    Patients

    Seq Age Sex Outcome Treatment
    1