BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 11403372 · Received March 3, 2021

    Report

    Report Number
    3012307300-2021-01682
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    December 1, 2020
    Report Date
    June 15, 2021
    Product Code
    BTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL BREATHING/PORTEX GENERAL ANESTHESIA CIRCUITS. SAMPLE UNIT FROM P/N C45101340-NLJ, L/N 4041484 RECEIVED AND TESTED. THE UNIT PASSED ALL FUNCTIONAL TESTING AND THE COMPLAINT WAS NOT CONFIRMED. DEVICE ENGINEERING REVIEWED AND PASSED AT 100% PRIOR TO RELEASE OF PRODUCT.

    Description of Event or Problem · 0

    DEVICE EVALUATION COMPLETED AND SUMMARY IN H 10.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL BREATHING/PORTEX GENERAL ANESTHESIA CIRCUITS MALFUNCTIONED. DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED AIR WAS LEAKING FROM IT. SO HE CHANGED IT TO ANOTHER NEW ONE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303065 PORTEX BREATHING CIRUCITS BTL 4041484

    Patients

    Seq Age Sex Outcome Treatment
    1