BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 2854240 · Received November 27, 2012

    Report

    Report Number
    2936999-2012-00619
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 31, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
    Product Code
    BTR
    PMA / PMN Number
    K873461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED THAT THE CUFF WOULD NOT INFLATE. CALLER CANNOT CONFIRM ANY ADD'L DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT. THE CALLER COULD NOT CONFIRM ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT LASER-FLEX TRACHEAL TUBE BTR COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1