BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL BREATHING CIRCUIT FILTER WITH FLEX TUBE

    MDR report key: 322514 · Received March 23, 2001

    Report

    Report Number
    2647898-2001-00004
    Event Type
    Other
    Date Received
    March 23, 2001
    Date of Event
    February 13, 2001
    Report Date
    February 20, 2001
    Manufacturer
    PALL BIOMEDICAL INC.
    Product Code
    CAH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SETTING UP TWO PTS ON VENTILATORS, THE THERAPIST NOTICED THAT THE PTS WERE IN RESPIRATORY DISTRESS. AFTER SUCTIONING THE PTS TWICE, THE THERAPIST NOTICED THE SECOND TIME THAT THE DEVICE'S CORRUGATED TUBES WERE COMPRESSING AND NOT ALLOWING FREE AIRFLOW TO THE PT. THE THERAPIST IMMEDIATELY REMOVED THE DEVICES FROM THE CIRCUIT AND CONTINUED VENTILATING WITHOUT THE DEVICE, WHICH RESOLVED AIRFLOW PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12903 PALL BREATHING CIRCUIT FILTER WITH FLEX TUBE BREATHING CIRCUIT FILTER CAH PALL BIOMEDICAL INC. BB100F 032106

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention