BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESPIRATORY BREATHING CIRCUIT

    MDR report key: 233188 · Received July 15, 1999

    Report

    Report Number
    1718887-1999-00001
    Event Type
    Other
    Date Received
    July 15, 1999
    Date of Event
    June 17, 1999
    Report Date
    July 15, 1999
    Manufacturer
    MARQUEST MEDICAL PRODUCTS INC
    Product Code
    BZO
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    CIRCUIT LEAKED. DETECTED A SMALL HOLE IN THE 90 DEGREE ELBOW BETWEEN THE INNER AND OUTER RING. CIRCUIT PASSED VENTILATOR PRESSURE TEST BECAUSE THE ELBOW DIAMETER IS SEALED ON THE OUTSIDE WITH THE BLUE CUP. DURING PT USE, THE 15MM ID OF THE ELBOW IS FIT WITH A TRACH TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY BREATHING CIRCUIT RESPIRATORY BREATHING CIRCUIT BZO MARQUEST MEDICAL PRODUCTS INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other