BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 6187349 · Received December 19, 2016

    Report

    Report Number
    1723170-2016-05861
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 25, 2016
    Report Date
    December 19, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ONSITE INSPECTION, THE MEDTRONIC REPRESENTATIVE REPORTED THAT THE BREAKER SWITCH ON THE BACK OF THE MOBILE VIEW STATION (MVS) HAD GOTTEN TRIPPED. THE BREAKER SWITCH WAS RESET WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SYSTEM WOULD NOT START AFTER CHARGING FOR A PERIOD OF TIME. NO PATIENT WAS PRESENT DURING THE TIME OF THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837939 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON)

    Patients

    Seq Age Sex Outcome Treatment
    1