BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL BREATHING SYSTEM FILTER

    MDR report key: 307074 · Received December 1, 2000

    Report

    Report Number
    9680602-2000-00007
    Event Type
    Other
    Date Received
    December 1, 2000
    Date of Event
    September 29, 2000
    Report Date
    October 17, 2000
    Manufacturer
    PALL NEWQUAY, LTD.
    Product Code
    CAH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN VENTILATING THE PT WITH A FACIAL MASK AND THE DEVICE, THE PT DESATURATED. THE ANESTHETIST IMMEDIATELY CHECKED THE DEVICE ON A VENTILATOR AT A 60L/MIN PEAK FLOW AND FOUND A DELTA P OF 22 MMHG WITH THE DEVICE AND 12 MMHG WITHOUT THE DEVICE. LATER ON THE USER DID NOT NOTICED ANYTHING ABNORMAL DURING A VISUAL EXAMINATION. THEY TESTED THE DEVICE AGAIN ON A VENTILATOR AT A 60L/MIN PEAK FLOW AND FOUND 1.5 CM H20 WITHOUT THE DEVICE AND 3 CM H20 WITH THE DEVICE. THEY DID NOT SUCCEED IN REPRODUCING WHAT HAPPENED DURING THE INDUCTION. NO PT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL BREATHING SYSTEM FILTER BREATHING SYSTEM FILTER CAH PALL NEWQUAY, LTD. BB25FG 009002

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention