BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 8302564 · Received February 4, 2019

    Report

    Report Number
    3004785967-2019-00185
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Date of Event
    January 9, 2019
    Report Date
    February 4, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS REFUSED BY THE SITE. 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 FOR A HIP PROCEDURE. IT WAS REPORTED THAT SITE WAS HAVING ISSUES CONNECTING THE IMAGING SYSTEM TO THE NAVIGATION SYSTEM. IT WAS FOUND THAT WHEN THE CUSTOMER CONNECTED THE IMAGING SYSTEM TO THE NETWORK TO GET THE WORKLIST AND PATIENT INFORMATION, THE SYSTEM CREATED A CONNECTION TO A PLANNING STATION ON THE SAME NETWORK AS THE IOR SOFTWARE WAS NOT ENABLED. THE IOR SYSTEM ENABLES THE CUSTOMER TO CHOOSE THE SYSTEM TO CONNECT TO. MEDTRONIC IMAGING AND NAVIGATION WERE ABORTED. THERE WAS NO PATIENT IMPACT REPORTED AND A LESS THAN ONE HOUR DELAY TO SURGERY. LATER INVESTIGATION FOUND THAT THE SYSTEM HAD NOT BEEN DEFECTIVE. THE ISSUE OCCURRED BECAUSE OF MISSING TRAINING AND IOR BEING INACTIVE. THE TRAINING HAS SINCE BEEN PROVIDED AND THE IOR ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93661 O-ARM IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000

    Patients

    Seq Age Sex Outcome Treatment
    1