BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR, OPTIVANTAGE DH

    MDR report key: 2340255 · Received November 2, 2011

    Report

    Report Number
    1518293-2011-00203
    Event Type
    Malfunction
    Date Received
    November 2, 2011
    Date of Event
    October 10, 2011
    Report Date
    October 10, 2011
    Manufacturer
    COVIDIEN
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) ARRIVED ON-SITE AND WAS UNABLE TO DUPLICATE THE ISSUE. THE CUSTOMER WAS UNSURE WHAT PROTOCOL WAS USED, BUT THE FSE STATED NOTHING IN THE INJECTION HISTORY SHOWS SIDE B EVER BEING USED. PROPER OPERATION OF THE INJECTOR WAS VERIFIED PER SERVICE MANUAL 844962 AND SERVICE CHECKLIST 844864. CTS HISTORY SEARCH SHOWS NO OTHER SIMILAR ISSUES WITH THIS UNIT.

    Description of Event or Problem · 1

    ON (B)(6) 2011: CUSTOMER REPORTS VIA PHONE THAT WHILE TRYING TO INJECT CONTRAST WITH A SYRINGE LOADED ON SIDE A, SIDE B ACTUALLY MOVED TO INJECT. THERE WAS NO SYRINGE LOADED ON SIDE B AT THE TIME. THE CUSTOMER STATES THAT THERE WAS 68CC OF CONTRAST LOADED IN THE SYRINGE BUT HE DOES NOT RECALL THE INJECTION PROTOCOL. NO PATIENT INFORMATION PROVIDED. PROCEDURE WAS COMPLETED VIA HAND INJECTION. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTOR, OPTIVANTAGE DH CT POWER INJECTOR SYSTEM IZQ COVIDIEN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK