BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 7259976 · Received February 9, 2018

    Report

    Report Number
    1723170-2018-00619
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 17, 2018
    Report Date
    April 16, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT THE POWER CONVERSION ENCLOSURE WAS REPLACED WITHOUT RESOLUTION. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE POWER CONVERSION ENCLOSURE CHARGER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. TESTING FOUND THAT TWO TRANSISTORS ON THE CHARGER WERE REMOVED.

    Additional Manufacturer Narrative · 1

    CORRECTION: AWARE DATE OF SUPPLEMENTAL REPORT 2 INADVERTENTLY FILED AS 1/28/2018. CORRECT VALUE SHOULD HAVE BEEN 1/28/2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE A SECOND CHARGER ENCLOSURE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE CHARGER WAS FOUND TO BE FULLY FUNCTIONAL AND THE REPORTED ISSUE COULD NOT BE REPLICATED. THE GROUND FAULT INTERRUPTER (GFI) CABLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN INSTALLED IN A KNOWN OPERATIONAL IMAGING SYSTEM, THE SYSTEM DISPLAYED A GFI FAULT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT GFI-TESTING FAILED. THE GFI CABLE GROUND ASSY AND ENCLOSURE CHARGER BOARD WERE BOTH REPLACED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE PERFORMING A PLANNED MAINTENANCE (PM), THE IMAGING SYSTEM FAILED GFI TESTING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT DURING PLANNED MAINTENANCE (PM), THE GFI TEST FAILED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103631 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON)

    Patients

    Seq Age Sex Outcome Treatment
    1