BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-LO

    MDR report key: 1010522 · Received February 20, 2008

    Report

    Report Number
    1010522
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 20, 2008
    Manufacturer
    COVIDIEN MALLINCKRODT
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BLUE INFLATION BULB WAS NOT CONSISTENTLY STAYING INFLATED, NOR WOULD IT DEFLATE PROPERLY ON SEVERAL DEVICES FROM THE SAME LOT. THE DEFECTIVE DEVICES WERE NOT USED ON ANY PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-LO TUBE, TRACHEAL BTR COVIDIEN MALLINCKRODT * 071100

    Patients

    Seq Age Sex Outcome Treatment
    1 *