BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH ROBERTSHAW EB TUBE, RIGHT

    MDR report key: 2922184 · Received January 16, 2013

    Report

    Report Number
    8040412-2013-00028
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 19, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE BRONCHIAL CUFF DOESN'T INFLATE CORRECTLY AND HAS CAUSED AIR LEAKS AND PROBLEMS WITH THE PT'S VENTILATION. THE PT WAS RE-INTUBATED. CONDITION OF PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23908 RUSCH ROBERTSHAW EB TUBE, RIGHT ENDOBRONCHIAL TUBE JOH TELEFLEX MEDICAL 12BE08

    Patients

    Seq Age Sex Outcome Treatment
    1