BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX GENERAL ANESTHESIA CIRCUITS

    MDR report key: 11454860 · Received March 10, 2021

    Report

    Report Number
    3012307300-2021-01847
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    December 22, 2020
    Report Date
    June 15, 2021
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS MEDICAL BREATHING/PORTEX GENERAL ANESTHESIA CIRCUITS . TWO PICTURES ATTACHED. SAMPLE UNIT FROM P/N C49291349-NLJ, L/N 3973619. THE DEVICE WAS VISUALLY INSPECTED AND NO ABNORMALITIES NOTED. TESTING WAS DONE AND THE UNIT PASSED THE LEAK TEST. COMPLAINT WAS NOT CONFIRMED AS DEVICE PASSED ALL TESTING.

    Description of Event or Problem · 0

    DEVICE EVALUATION COMPLETED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: (B)(6). DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRE-USE CHECK, AN AIR LEAK WAS DETECTED IN THE PORTEX GENERAL ANESTHESIA CIRCUIT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354629 PORTEX GENERAL ANESTHESIA CIRCUITS CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI SMITHS MEDICAL INTERNATIONAL, LTD. 3973619

    Patients

    Seq Age Sex Outcome Treatment
    1