BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL BREATHING SYSTEM FILTER

    MDR report key: 304559 · Received November 13, 2000

    Report

    Report Number
    9680602-2000-00004
    Event Type
    Other
    Date Received
    November 13, 2000
    Date of Event
    September 14, 2000
    Report Date
    September 27, 2000
    Manufacturer
    PALL NEWQUAY, LTD.
    Product Code
    BYD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 15 MINUTES AFTER INDUCTION, THE DOCTOR NOTICIED A SEVERE AIRWAY RESISTANCE. THE PT HAD STARTED TO BECOME HYPOXIC. THEY QUICKLY CHECKED THE MACHINE AND REMOVED THE DEVICE. AFTER THE DEVICE WAS REMOVED THE AIRWAY RESISTANCE RETURNED TO NORMAL AND THE OXYGENATION AND VERTILATION WERE SATISFACTORY. THE OPERATION WAS RESUMED WITH A FILTER. THERE WAS NO SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL BREATHING SYSTEM FILTER SMALL VOLUME HME EXCHANGER BYD PALL NEWQUAY, LTD. BB25 007302

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R