BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 2903811 · Received January 2, 2013

    Report

    Report Number
    2936999-2012-00729
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE SAMPLE IS RETURNED, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER IS REPORTING THAT THE CUFF FAILED TO INFLATE WHEN TESTED PRIOR TO INSERTION. CALLER STATES THAT THE ETT SS ARE KEPT ON THE ANESTHESIA CART AND THE ETT S ARE NOT WARMED. CALLER STATES THAT THERE WAS NOT PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346 MALLINCKRODT HI-LO TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO 120701677X

    Patients

    Seq Age Sex Outcome Treatment
    1