BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL SMALL VOLUME HME FILTER

    MDR report key: 243753 · Received October 7, 1999

    Report

    Report Number
    9680602-1999-00009
    Event Type
    Other
    Date Received
    October 7, 1999
    Date of Event
    August 25, 1999
    Report Date
    September 6, 1999
    Manufacturer
    PALL NEWQUAY, LTD.
    Product Code
    BYD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS PRESENT AT THE PT END OF AN ANAESTHETIC CIRCUIT. AFTER APPROXIMATELY FIVE MINUTES, THE VENTILATOR SIGNALED THAT THERE WAS AN INCREASED RESISTANCE IN THE CIRCUIT. THIS PHENOMENON REPORTEDLY HAPPENED ON SEVEN DIFFERENT OCCASIONS WITH TWO PTS. EXAMINATION OF THE DEVICES BY THE HOSPITAL STAFF REVEALED THAT THERE WAS NO LIQUID IN THE FILTER HOUSING. TESTING OF THE IMPLICATED DEVICES IN THE HOSPITAL WITH A RESERVOIR BAG REPORTEDLY SHOWED THAT THE DEVICES EXHIBITED A HIGHER THAN NORMAL RESISTANCE TO FLOW, BUT WERE NOT COMPLETELY BLOCKED. NO PT SEQUELAE WERE REPORTED. ALSO SEE REPORT: 9680602-1999-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL SMALL VOLUME HME FILTER HEAT AND MOISTURE EXCHANGER BYD PALL NEWQUAY, LTD. BB25 916801

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention