BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOFLO FILTER PORT

    MDR report key: 501671 · Received December 5, 2003

    Report

    Report Number
    MW1030504
    Event Type
    Injury
    Date Received
    December 5, 2003
    Date of Event
    November 24, 2003
    Report Date
    December 5, 2003
    Manufacturer
    ARC MEDICAL, INC.
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    HEAT MOISTURE EXCHANGE FILTER SUDDENLY OCCLUDES, WHILE IN USE ON MECHANICALLY VENTILATED PTS. NO APPARENT CAUSE, AS FILTER IS NOT COVERED WITH SECRETIONS, MUCUS, OR PULMONARY EDEMA. PEAK INSPIRATORY PRESSURES SUDDENLY INCREASE, AND PTS CANNOT TRIGGER A BREATH FROM MACHINE. NOTE: FACILITY HAS USED PERHAPS 25,000 FILTERS IN PAST 6 YEARS, WITH ONLY 3-4 OCCLUSIONS PER YEAR, WITH OBVIOUS CAUSES. THEY HAVE EXPERIENCED 6 IN PAST 10 DAYS WITH NO APPARENT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOFLO FILTER PORT HEAT MOISTURE EXCHANGER FILTER JOJ ARC MEDICAL, INC. 6020A 030850-50

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention