BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE DH

    MDR report key: 809718 · Received January 24, 2007

    Report

    Report Number
    1518293-2007-00001
    Event Type
    Injury
    Date Received
    January 24, 2007
    Date of Event
    January 8, 2007
    Report Date
    January 8, 2007
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    1/12/07; VERIFIED CALIBRATION ACCURACY ACCORDING TO CHAPTER 4 OF SERVICE AND PARTS MANUAL (P/N 844962-C). ALL WITHIN SPEC'S. NO PROBLEM'S FOUND WITH THE INJECTOR. (ADD'L NOTE) HOSP PERSONNEL NOT OPEN WITH DETAILS OF EVENT, BUT EVENT MAY HAVE HAPPENED SHORTLY AFTER INSTALLATION OF 12/06. HOSP MAIN POINT OF CONTACT WON'T RETURN ANY FORM OF COMMUNICATION PERTAINING TO UNIT.

    Description of Event or Problem · 1

    LF CUSTOMER SUPPORT REPORTS VIA FAX, CUSTOMER CALLED TO REPORT, PT WAS INJECTED WITH AIR. PT CURRENTLY IN ICU. SPOKE WITH CUSTOMER DEPT SUPERVISOR. IT IS INDICATED THAT OPTIRAY 320 PREFILLED, 125ML SYRINGE WAS BEING USED BY REGISTERED STAFF DURING A PROCEDURE. SUPERVISOR INDICATES THAT THE STAFF BYPASSED THE SETUP FEATURES OF THE SYSTEM. SUPERVISOR FEELS THAT THE INCIDENT IS HUMAN ERROR, BUT WANTS SYSTEM CHECKED OUT. REFERRED TO MGMT FOR PT INFO. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIVANTAGE DH CT POWER INJECTOR IZQ LIEBEL-FLARSHEIM CO. OPTIVANTAGE DH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other