BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL BREATHING CIRCUIT FILTER

    MDR report key: 234205 · Received July 30, 1999

    Report

    Report Number
    2432733-1999-00010
    Event Type
    Other
    Date Received
    July 30, 1999
    Date of Event
    April 23, 1999
    Report Date
    April 30, 1999
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO
    Product Code
    CAH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER 120 HOURS OF USE A PT COMPLAINED OF STIFLING ON A SERVO 300 VENTILATOR WITH THE DEVICE. INVESTIGATION BY THE FACILITY'S MEDICAL ENGINEER REVEALED RESISTANCE OF EXPIRATION. NO PT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL BREATHING CIRCUIT FILTER BREATHING CIRCUIT FILTER CAH PALL BIOMEDICAL PRODUCTS CO BB50T UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention