BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC ISOFLEX BREATHING CIRCUIT

    MDR report key: 169779 · Received May 26, 1998

    Report

    Report Number
    6000001-1998-00345
    Event Type
    Malfunction
    Date Received
    May 26, 1998
    Date of Event
    May 1, 1998
    Report Date
    May 1, 1998
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION F COMPLETED BY BAXTER. ONE USED DISPOSABLE ANESTHESIA BREATHING BAG WAS RETURNED FOR EVALUATION. THE BAG BUSHING WAS SEPARATED FROM THE BAG AND THE SECURING TAPE WAS MISSING FROM THE BUSHING. THE CONDITION OF THE RETURNED SAMPLE DOES NOT ALLOW A CONCLUSION FOR WHEN THIS COULD HAVE OCCURRED. THERE ARE NO OTHER ISSUES REPORTED FOR THIS PRODUCT CODE OR LOT.

    Description of Event or Problem · 1

    REPORTEDLY THE BAG WAS "SUCCESSFULLY PRESSURE TESTED TO APPROX 30-40CM" PRIOR TO USE. THE BAG BECAME LOOSE AND SEPARATED FROM THE ANESTHESIA MACHINE IN THE ANESTHETISTS HAND DURING MASK INDUCTION. IT WAS REPLACED BY ANOTHER BAG WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIATRIC ISOFLEX BREATHING CIRCUIT ANESTHESIA BREATHING CIRCUIT CAI ALLEGIANCE HEALTHCARE CORP NA Y8B0580

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ANESTHESIA MACHINE