BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITHS MEDICAL PORTEX HYPERINFLATION RESUSCITATION MANOMETERS

    MDR report key: 8906419 · Received August 19, 2019

    Report

    Report Number
    3012307300-2019-04040
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    July 15, 2019
    Report Date
    August 19, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KRK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT DURING VERIFICATION OF THE CUFF OF A SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE, THE MANOMETER INDICATED "ZERO PRESSURE" WHILE THE CUFF APPEARED TO BE OVER INFLATED. THIS OCCURRED ONCE AGAIN ON THE SECOND ATTEMPT. ON THE THIRD TEST WITH A DIFFERENT MANOMETER, IT ALSO INDICATED "ZERO PRESSURE". WHILE TESTING THE THIRD TIME, THE USER NOTED THE TRACHEAL TUBE HAD CAUSED HAEMODYNAMIC LABILITY ON LEAKS OF FORENE SOLUTION, AND THE BENCHMARK TRACHEAL TUBE HAD SLIPPED TWO CENTIMETERS. IMMEDIATELY, PATIENT WAS SECURED FOR REPOSITIONING OF THE TRACHEAL TUBE AND REINTUBATION. THE PATIENT WAS THEN STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700168 SMITHS MEDICAL PORTEX HYPERINFLATION RESUSCITATION MANOMETERS MANOMETER, BLOOD-PRESSURE, VENOUS KRK SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention