BEUDAMED
    FDA Adverse Event Other Summary report: N

    INJECTOR, OPTIVANTAGE DH

    MDR report key: 884030 · Received July 20, 2007

    Report

    Report Number
    1518293-2007-00011
    Event Type
    Other
    Date Received
    July 20, 2007
    Date of Event
    June 26, 2007
    Report Date
    June 27, 2007
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBLE FLARSHEIM FIELD SERVICE ENGINEER REPORT: OPTIVANTAGE DH INJECTOR SYSTEM WAS EVALUATED FOR PROPER FUNCTION PER OPTIVANTAGE DH SERVICE MANUAL, P/N 844962, MAINTENANCE SECTION 4.2. ALL SYSTEM FUNCTIONS VERIFIED WITHIN SPECIFICATIONS. INJECTOR SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    LF FSE REPORTS VIA FAX, CUSTOMER REPORTS AN AIR INJECTION. PT DOES NOT HAVE PERMANENT OR SEVERE INJURY. CUSTOMER DOES NOT BELIEVE IT IS OUR EQUIPMENT, BUT WANTS EQUIPMENT CHECKED OUT FOR SAFETY REASONS. CUSTOMER STILL USING EQUIPMENT. ON 6/27: CUSTOMER REPORTS TO CPM THAT THEY BELIEVE AIR CAME FROM SEPARATE IV LINE. STAFF REPORTS THERE WAS NO AIR IN IV LINE, BUT THE TECHNOLOGIST STATES, THEY SAW AIR BUBBLES IN THE IV LINE. CUSTOMER RESTATED, THAT THEY FEEL THE INJECTOR WAS NOT THE ORIGIN OF THE AIR. VOLUME OF AIR WAS NOT REPORTED, BUT BUBBLES WERE REFERENCED. CUSTOMER HAD INJECTOR SYSTEM CHECKED FOR SAFETY REASONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR