BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERGUARD EVAC

    MDR report key: 2061439 · Received March 30, 2011

    Report

    Report Number
    2061439
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 30, 2011
    Manufacturer
    COVIDIEN NELLCOR MALLINCKRODT
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    RN NOTICED THAT PT WAS NOT RECEIVING TIDAL VOLUMES FROM VENTILATOR. VENT ALARM BEEPING "LOW TIDAL VOLUMES." IT SOUNDED LIKE THE CUFF OF THE ENDOTRACHEAL TUBE WAS BLOWN. (B) (6) RULED OUT THE BALLOON FOR AIR LEAK. DR CAME TO RE-INTUBATE PT. PT HAD GOOD BREATH SOUNDS AND O2 SATS OF 100% DURING THE WHOLE EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERGUARD EVAC ENDOTRACHEAL TUBE BTR COVIDIEN NELLCOR MALLINCKRODT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR