BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6172286 · Received December 13, 2016

    Report

    Report Number
    1723170-2016-05788
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 17, 2016
    Report Date
    December 13, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED AT THE TIME OF THIS EVENT. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. EVENT PROBLEM AND EVALUATION: * ON 23-NOV-2016, A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. AFTER REPLACING THE UNINTERRUPTIBLE POWER SUPPLY (UPS) BATTERIES, AN IMAGING SYSTEM CHECK-OUT WAS COMPLETED; THE MECHANICAL TESTS, IMAGING TESTS AND SAFETY INSPECTION ALL PASSED; SYSTEM PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THE IMAGING SYSTEM¿S MOBILE VIEW STATION (MVS) BATTERIES DROP CHARGE IN LESS THAN A MINUTE. THIS ISSUE WAS DISCOVERED OUTSIDE OF SURGERY, NO PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821667 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00027-120

    Patients

    Seq Age Sex Outcome Treatment
    1