BEUDAMED
    FDA Adverse Event Summary report: N

    GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN

    MDR report key: 2143477 · Received April 28, 2011

    Report

    Report Number
    3003900188-2011-00017
    Date Received
    April 28, 2011
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: LIV VALVE DEFECT, NO PT HARM.

    Description of Event or Problem · 1

    ON (B)(6) 2011, LINDE WAS INITIALLY INFORMED THAT AN INCIDENT INVOLVING A GCE LIV VALVE HAD OCCURRED IN (B)(6) ON THE SAME DAY. NO PERSON WAS INJURED. WHILE THE HOSP MAINTENANCE PERSONNEL WAS REVIEWING THE CYLINDER'S LIV, THEY PERCEIVED THAT THE VALVE DID NOT WORK BECAUSE THE OXYGEN DID NOT LEAVE THROUGH THE EXIT UNIT. ACCORDING TO AVAILABLE INFO THE OXYGEN CYLINDER WAS FULL. ADD'L INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN NONE ECX 0710160

    Patients

    Seq Age Sex Outcome Treatment
    1