BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL BREATHING SYSTEM FILTER

    MDR report key: 306725 · Received December 1, 2000

    Report

    Report Number
    9680602-2000-00005
    Event Type
    Other
    Date Received
    December 1, 2000
    Date of Event
    October 18, 2000
    Report Date
    October 20, 2000
    Manufacturer
    PALL NEWQUAY, LTD.
    Product Code
    BYD
    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 THE USER COULD NOT VENTILATE THE PT BECAUSE OF THE DEVICE. THE USER WAS TRYING TO INDUCE ANESTHESIA, BUT USER KNEW BEFORE THE INDUCTION THAT USER WOULD HAVE DIFFICULTY VENTILATING THE PT BECAUSE BECAUSE THE PT PRESENTED ANATOMIC CHARACTERISTICS FOR A DIFFICULT INTUBATION. BEFORE THE INDUCTION THE USER CHECKED THE MANUAL CIRCUIT WITHOUT THE DEVICE AND EVERYTHING WAS FINE. WHEN USER BEGAN THE INDUCTION AND VENTILATION WITH THE FACIAL MASK USER NOTICED THAT THE PT RAPIDLY DESATURATED AND THAT THE USER'S ASSISTANT HAD DIFFICULTIES VENTILATING THE PT MANUALLY. THE DOCTOR ATTRIBUTED THE VENTILATION DIFFICULTIES TO THE ANATOMIC CHARACTERISTICS OF THE PT, HOWEVER, THE PT RAPIDLY BECAME UNABLE TO BE VENTILATED. THE USER AWOKE THE PT AND NOTICED THAT THE PT HAD NO INDICATION ON THE C02 MONITOR ALTHOUGH THE PT WAS VENTILATING SPONTANEOUSLY. USER SUSPECTED THE DEVCE. SURGERY WAS POSTPONED TO THE NEXT DAY. AFTER ASSURING THE PT WAS FINE USER INVESTIGATED ALL THE PARTS OF THE CIRCUIT AND DISCOVERED THAT THE DEVICE WAS TOTALLY BLOCKED. VERY HIGH PRESSURE HAD TO BE APPLIED ONTO THE BAG TO OBTAIN A VERY THIN STREAM OF AIR. IN SPITE OF THE EPISODE OF DESATURATION THE PT IS FINE, HOWEVER BECAUSE OF SEVERAL MANEUVERS IN THE MOUTH, A TOOTH HAD BEEN DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL BREATHING SYSTEM FILTER BREATHING SYSTEM FILTER BYD PALL NEWQUAY, LTD. BB25F 020802

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R