BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAW

    MDR report key: 7929402 · Received October 3, 2018

    Report

    Report Number
    3004785967-2018-00013
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    September 6, 2018
    Report Date
    January 15, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION WAS RECEIVED THAT THE SITE DISCARDED THE PART, THEREFORE NO ANALYSIS IS POSSIBLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #O2 SCAN ISSUE. 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 THAT AS SOON AS THE 3D IMAGE WAS ACQUIRED, THE MOBILE VIEWING STATION (MVS) FAILED TO SHOW THE NEWLY SCANNED "TC" AND AS A CONSEQUENCE NO EXAM TRANSFERRED TO THE NAVIGATION SYSTEM. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770605 HAW INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000

    Patients

    Seq Age Sex Outcome Treatment
    1