BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL SMALL VOLUME HME FILTER

    MDR report key: 181641 · Received August 11, 1998

    Report

    Report Number
    9680602-1998-00002
    Event Type
    Other
    Date Received
    August 11, 1998
    Date of Event
    June 10, 1998
    Report Date
    July 9, 1998
    Manufacturer
    PALL NEWQUAY LTD.
    Product Code
    BYD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE DEVICE WAS IN USE DURING ANESTHESIA, AIRWAY PRESSURE INCREASED. THE PT'S BLOOD PRESSURE ALSO INCREASED FROM 100/60 TO 160/120. THE CUSTOMER QUESTIONED WHETHER THE DEVICE WAS BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL SMALL VOLUME HME FILTER HEAT & MOISTURE EXCHANGER BYD PALL NEWQUAY LTD. BB25 804401

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention