BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 11947937 · Received June 7, 2021

    Report

    Report Number
    3004785967-2021-00727
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 7, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OWB
    UDI-DI
    00643169639683
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE CHARGER ENCLOSURE WAS REPLACED. . THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ANALYSIS ON THE RETURNED CHARGER ENCLOSURE SHOWED NO FAILURE FOUND WHEN ANALYZED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: BI71000175, LOT#: REV. 2 : S/N (B)(4). 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 DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN POWERING ON THE SYSTEM THE IMAGE ACQUISITION SYSTEM (IAS) WILL NOT INITIALIZE. THE SITE TIRED MULTIPLE REBOOTS BUT THE IAS REMAINS ON "INITIALIZING PLEASE WAIT" INCLUDING REBOOTS WITH THE MOBILE VIEW STATION (MVS) DISCONNECTED TO THE IAS WITH NO RESOLUTION. THE MVS WOULD OCCASIONALLY HAVE A FIRMWARE MISMATCH ERROR. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844833 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000 00643169639683

    Patients

    Seq Age Sex Outcome Treatment
    1