BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8020889-2018-00051

    MDR report key: 7512093 · Received May 14, 2018

    Report

    Report Number
    8020889-2018-00051
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Report Date
    May 14, 2018
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE UNIT HAD A SMALL CHIP IN THE BOTTOM OF THE TRACH TUBE. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355656 BTR MALLINCKRODT MEDICAL UNKTRACH

    Patients

    Seq Age Sex Outcome Treatment
    1