BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3871488 · Received April 16, 2014

    Report

    Report Number
    2936999-2014-00345
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER STATES: PRIOR TO USE, IT WAS OBSERVED THAT THE CUFF WOULD NOT DEFLATE. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233165 MALLINCKRODT ENDOBROCHIAL TUBE LEFT/RIGHT BTS COVIDIEN 201308211X

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown