BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 1633072 · Received March 11, 2010

    Report

    Report Number
    MW5015151
    Event Type
    Malfunction
    Date Received
    March 11, 2010
    Date of Event
    January 6, 2010
    Report Date
    March 11, 2010
    Manufacturer
    COVIDIEN-NELLCOR
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRACH BROKE AT THE TOP WHERE THE VENTILATOR CONNECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN SHILEY TRACH BTO COVIDIEN-NELLCOR

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR