BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADULT ANESTHESIA BREATHING CIRCUIT

    MDR report key: 743444 · Received June 9, 2005

    Report

    Report Number
    MW1035701
    Event Type
    Other
    Date Received
    June 9, 2005
    Date of Event
    June 2, 2005
    Report Date
    June 8, 2005
    Manufacturer
    UNOMEDICAL INC
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ANESTHESIA BREATHING CIRCUIT O2 RESERVOIR BAG HAD HOLE. UNSURE HOW IT OCCURRED - WOULD NOT ALLOW PRESSURE TO VENTILATOR. NO ADVERSE EFFECTS TO PT. PT WAS INTUBUTED AND AMBUED DURING CHANGE OF BREATHING CIRCUIT AND BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT ANESTHESIA BREATHING CIRCUIT BREATHING CIRCUIT CAI UNOMEDICAL INC LBIAC AC 7000 05-03

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other