BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-LO

    MDR report key: 1190373 · Received October 3, 2008

    Report

    Report Number
    2936999-2008-00431
    Event Type
    Injury
    Date Received
    October 3, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER. RETURN OF THE ENDOTRACHEAL TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE NEW OR SIGNIFICANT INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HILO ENDOTRACHEAL TUBE CUFF DEFLATED. IT WAS REPORTED THAT THE RESPIRATORY THERAPIST ADDED AIR TO THE CUFF SOME TIME BEFORE IT DEFLATED AND THE PATIENT WAS RE-INTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-LO ENDOTRACHEAL TUBE BTR COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention