BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    44" EXTENSION SET WITH VALVES

    MDR report key: 178424 · Received July 20, 1998

    Report

    Report Number
    1627487-1998-00021
    Event Type
    Malfunction
    Date Received
    July 20, 1998
    Date of Event
    June 1, 1998
    Report Date
    July 20, 1998
    Manufacturer
    QMI
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SETS DEMONSTRATED RETROGRADE FLOW THROUGH THE IN-LINE. NO PT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 44" EXTENSION SET WITH VALVES ANESTHESIA DELIVERY SET FPA QMI 9620 8594.X08

    Patients

    Seq Age Sex Outcome Treatment
    1 *