BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDI - TUBE - TRACHEAL TUBE

    MDR report key: 1013921 · Received March 12, 2008

    Report

    Report Number
    MW5005882
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 12, 2008
    Manufacturer
    VITAL SIGNS, INC
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ENDO TRACHEAL TUBE AIR-BULB INDICATOR DOES NOT WORK PROPERLY. SHOULD BE INFLATED WHEN CUFF IS INFLATED, SHOULD BE DEFLATED WHEN CUFF IS DEFLATED. PRODUCT DOES NOT INDICATE THIS. DATES OF USE, 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDI - TUBE - TRACHEAL TUBE REDI-TUBE BTR VITAL SIGNS, INC R8080RTC 711021679

    Patients

    Seq Age Sex Outcome Treatment
    1