BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 2903848 · Received January 2, 2013

    Report

    Report Number
    2936999-2012-00732
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE FOR ANALYSIS.

    Description of Event or Problem · 1

    CALLER STATES THAT IT WAS REPORTED BY (B)(6) THAT AS SOON AS THE PT ENTERED THE MRI ROOM, THE PILOT BALLOON STARTED TO LEVITATE AND WAS THEN TAPED TO THE PT. CALLER STATES THAT THERE WAS NO PT HARM AND MRI SCAN COMPLETED WITHOUT FURTHER INCIDENT. CALLER CONFIRMED THAT THERE IS NO LOT AND THE ETT IS IN THE PT AND WILL NOT BE REMOVED FOR THIS INCIDENT. ON (B)(4) 2012, NEW INFORMATION WAS RECEIVED INDICATING THE FOLLOWING: THE PT WAS EXTUBATED BASED ON THE MRI RESULTS. PLANNED EXTUBATION WITH NO RE-INTUBATION DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310 MALLINCKRODT HI-LO TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1