BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 7064504 · Received November 28, 2017

    Report

    Report Number
    1723170-2017-04847
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    October 31, 2017
    Report Date
    March 13, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: MEDTRONIC REPRESENTATIVE REPORTED THAT THE DEVICE COULD NOT BE REPAIRED AND THE SYSTEM WAS REPLACED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE IMAGING SYSTEM WAS REPLACED. THE IMAGING SYSTEM WAS RETURNED TO THE MANUFACTURER. TESTING FOUND THAT THE REPORTED ISSUE COULD BE REPLICATED. IT WAS NOTED THAT THE COMPUTER OF THE IMAGING SYSTEM AND VECTOR DONGLE WERE REPLACED TO RESTORE FUNCTIONALITY. THE DONGLE AND COMPUTER HAVE NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION PROCEDURE, POST LWZ L4 L5 FUSION, THERE WAS NO REACTION WHEN THE IMAGING SYSTEM MUST BE PLACED IN ANTERIOR POSITION OR LATERAL POSITION AFTER PARKING POSITION. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF MORE THAN 1 HOUR DUE TO THIS ISSUE AND NO IMPACT ON THE PATIENT OUTCOME. THE PROCEDURE WAS COMPLETED WITHOUT THE NAVIGATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842872 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON)

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR