BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL BREATHING SYSTEM FILTER

    MDR report key: 256493 · Received December 23, 1999

    Report

    Report Number
    9680602-1999-00014
    Event Type
    Other
    Date Received
    December 23, 1999
    Date of Event
    November 27, 1999
    Report Date
    December 2, 1999
    Manufacturer
    PALL NEWQUAY LTD.,
    Product Code
    BYD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER 8 HOURS OF VOLUME VENTILATION, FLOW RESISTANCE INCREASED. THE PT WAS REMOVED FROM THE BREATHING CIRCUIT CONTAINING THE DEVICE, AND MANUALLY VENTILATED, WITHOUT EXCESS RESISTANCE. WHEN THE PT WAS RETURNED TO THE ORIGINAL CIRCUIT, FLOW WAS BLOCKED, EVEN WHEN THE VENTILATOR'S PRESSURE SETTING WAS INCREASED. THE PT WAS RE-INTUBATED AND ANOTHER VOLUME VENTILATOR WAS SUBSTITUTED WITHOUT REDUCTION OF FLOW RESISTANCE. THEN THE DEVICE WAS REMOVED FROM THE CIRCUIT AND FLOW WAS RESUMED. BLOCKAGE OF THE DEVICE WAS VERIFIED BY STAFF ATTEMPTING UNSUCCESSFULLY TO BREATH THROUGH THE DEVICE. THE DEVICE DID NOT APPEAR TO BE WET OR CONTAIN ACCUMULATED SECRETIONS. IT WAS REPORTED THAT THE PT HAD DEVELOPED A PNEUMOTHORAX AS A RESULT OF THIS OCCURRENCE. THE PT IS IN SATISFACTORY CONDITION AND IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL BREATHING SYSTEM FILTER HEAT & MOISTURE EXCHANGER FILTER BYD PALL NEWQUAY LTD., BB25S 99-1010

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention