BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5706042 · Received June 8, 2016

    Report

    Report Number
    1723170-2016-01083
    Event Type
    Malfunction
    Date Received
    June 8, 2016
    Date of Event
    May 10, 2016
    Report Date
    June 8, 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 WAS INVOLVED WITH THIS EVENT, SO NO PATIENT DEMOGRAPHICS ARE APPLICABLE. A MEDTRONIC REPRESENTATIVE INSPECTED THE IMAGING SYSTEM ON-SITE, AND THE DAMAGED PART WAS EVALUATED BY THE MANUFACTURER. ANALYSIS OF THE RETURNED PART CONFIRMED THE REPORTED PROBLEM "DAMAGED J7 CONNECTOR DURING INSPECTION. SF- J-7 CONNECTOR DAMAGED." VISUAL INSPECTION CONFIRMS ELECTRICAL OVERSTRESS IS EVIDENT ON BATTERY CONNECTOR PINS OF J7. CONTINUITY TESTING VERIFIES THE BATTERY CONNECTOR HARNESS IS FUNCTIONAL. ON-SITE INVESTIGATION REVEALED THE ROOT CAUSE OF THE REPORTED MELTING WAS THE FACT THAT THE REPRESENTATIVE INCORRECTLY SET THE VOLT METER DURING SERVICE, AND SHORTED ONE OF THE CONNECTOR PINS. THIS DIRECTLY CAUSED THE REPORTED DAMAGE. THE PART WAS REPLACED AND THE ISSUE WAS RESOLVED. A FULL IMAGING SYSTEM CHECK-OUT WAS COMPLETED FOLLOWING PART REPLACEMENT AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE J7 CONNECTOR WITHIN THE ELECTRICAL CIRCUITRY OF THE SYSTEM WAS SLIGHTLY MELTED AND REQUIRING REPLACEMENT. THIS WAS DISCOVERED DURING A SCHEDULED ROUTINE SERVICE VISIT, AND OUTSIDE OF ANY PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361331 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