BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEAL TUBE

    MDR report key: 12657962 · Received October 19, 2021

    Report

    Report Number
    3012307300-2021-10086
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    September 1, 2021
    Report Date
    October 19, 2021
    Product Code
    LNZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER, OTHER TEXT: ONE UNIT RETURNED FOR INVESTIGATION. UPON VISUAL INSPECTION, THE DEVICE WAS FOUND KINKED. WHEN INFLATED 10 TIMES, NO PRESSURE DROP WAS OBSERVED SO THE CUSTOMER COMPLAINT IS NOT CONFIRMED. NO DHR REVIEW WAS DONE DUE TO NO FAULT BEING FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, LEAKAGE OF AIR FROM THE CUFF PRESSURE GAUGE WAS OBSERVED. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555696 TRACHEAL TUBE LNZ 4110355

    Patients

    Seq Age Sex Outcome Treatment
    1