BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPOR-PHASE

    MDR report key: 230069 · Received June 30, 1999

    Report

    Report Number
    MW1016659
    Event Type
    Malfunction
    Date Received
    June 30, 1999
    Date of Event
    June 8, 1999
    Report Date
    June 17, 1999
    Manufacturer
    RESPIRATORY SUPPORT PRODUCTS,INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    RESPONDED TO VENTILATOR ALARM. FOUND CIRCUIT FULL OF H2O. REMOVED PT FROM VENTILATOR, BEGAN AMBU ASSIST. ANOTHER VENTILATOR WAS BROUGHT IN. PT'S O2 SAT DROPPED TO 70%. NURSE AMBUED PT AND O2 SAT INCREASED TO 93%. INVESTIGATION REVEALED LEAK IN TRANSFER CHAMBER MEMBRANE. TRANSFER CHAMBER RETURNED TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOR-PHASE TRANSFER CHAMBER BTT RESPIRATORY SUPPORT PRODUCTS,INC. * 1456

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other