BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 2992906 · Received February 28, 2013

    Report

    Report Number
    2936999-2013-00129
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 31, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTH
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES: DURING PRE-TEST PRIOR TO USE ON A PT A SUPPLIER FOUND THE CUFF WOULD NOT BE DEFLATED COMPLETELY. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87298 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN, FORMERLY TYCOHEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1