BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMALLINCKRODT

    MDR report key: 2872494 · Received December 11, 2012

    Report

    Report Number
    2936999-2012-00649
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 14, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER STATES: PRIOR TO USE, UPON RE-TEST A NURSE FOUND THE DEFLATION OF CUFF COULD NOT BE COMPLETED SUCCESSFULLY. CUSTOMER CONFIRMED NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN, FORMERLY TYCO HEALTHCARE 201206623X

    Patients

    Seq Age Sex Outcome Treatment
    1