BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6123280 · Received November 22, 2016

    Report

    Report Number
    1723170-2016-05510
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 22, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS EVENT. EVENT PROBLEM AND EVALUATION: ON (B)(6) 2016, A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE BATTERY CHARGER 1, BATTERY CHARGER 2, AND MOTOR BATTERY CHARGER BOARDS WERE FOUND TO BE BURNT. NEW BOARDS WERE INSTALLED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE BATTERY CHARGER 1 (PCBA) BOARD WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND AN ELECTRICAL FAILURE MODE WAS IDENTIFIED. THE BOARD FAILED VISUAL INSPECTION. MULTIPLE COMPONENTS SHOWED SIGNS OF ELECTRICAL OVER-STRESS. UNABLE TO BENCH TEST DUE TO ELECTRICALLY OVER-STRESSED COMPONENTS. THE BATTERY CHARGER 2 (PCBA) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND AN ELECTRICAL FAILURE MODE WAS IDENTIFIED. THE BOARD FAILED VISUAL INSPECTION. MULTIPLE COMPONENTS SHOWED SIGNS OF ELECTRICAL OVER-STRESS. UNABLE TO BENCH TEST DUE TO ELECTRICALLY OVER-STRESSED COMPONENTS. THE MOTOR BATTERY CHARGER PCBA WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND AN ELECTRICAL FAILURE MODE WAS IDENTIFIED. THE BOARD FAILED VISUAL INSPECTION. MULTIPLE COMPONENTS SHOWED SIGNS OF ELECTRICAL OVER-STRESS. UNABLE TO BENCH TEST DUE TO ELECTRICALLY OVER-STRESSED COMPONENTS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE, FOLLOWING UP WITH THE SITE, REPORTED THAT THE IMAGING SYSTEM¿S CHARGER BOARDS 1 AND 2 AS WELL THE MOTION MOTOR BATTERY CHARGER WERE ALL OUT OF SPECIFICATIONS. NO PATIENT WAS INVOLVED WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774064 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