BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIVANTAGE DH

    MDR report key: 6921889 · Received October 6, 2017

    Report

    Report Number
    1518293-2017-00024
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    September 11, 2017
    Report Date
    October 6, 2017
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K042744
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    PIECE OF METAL FELL OFF THE MACHINE. INCIDENT: A SMALL, FLAT, METALLIC PART FELL OFF THE OVERHEAD ARM SUPPORTING THE INJECTOR, AND STRUCK A PATIENT. THE OVERHEAD ARM WAS (LIKELY) MANUFACTURED IN OR BEFORE 2006 BY MAVIG. THERE WAS NO HARM TO THE PATIENT OR CAREGIVER AS A RESULT OF THE EVENT. THE REGIONAL SERVICE TECHNICIAN IDENTIFIED THE RELATIVELY SMALL METALLIC PART AS A FLAT SPRING STEEL GUARD, DESIGNED TO PROTECT THE MAVIG EXTENSION/SPRING ARM'S ACTIVE JOINTS FROM BECOMING A PINCH-POINT. SERVICE REPLACED THE BROKEN MAVIG EXTENSION/SPRING ARM (241063) & MAVIG J-BOW ARM (241079) TO REPAIR THE ISSUE. NOTE: BOTH THE EXTENSION/SPRING & J-BOW ARMS WERE REPLACED DUE TO THE INDIVIDUAL PIECES BEING BOUND TOGETHER, THEREFORE DIFFICULT TO SEPARATE AFTER LONG-TERM USE. AFTER THE REPAIR, SERVICE VERIFIED OPERATION ACCORDING TO TEST AND INSPECTION DATA CHECKLIST (844113). SINCE THE INJECTOR WAS FULLY FUNCTIONAL AND MET MANUFACTURER'S SPECIFICATIONS, IT WAS DETERMINED ACCEPTABLE FOR USE. A SEARCH OF COMPLAINT HISTORY INDICATED NO SIMILAR ISSUES WITH THIS UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705515 OPTIVANTAGE DH OPTIVANTAGE DH DXT LIEBEL-FLARSHEIM 844001

    Patients

    Seq Age Sex Outcome Treatment
    1