BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT CRITICAL CARE

    MDR report key: 156028 · Received March 13, 1998

    Report

    Report Number
    156028
    Event Type
    Malfunction
    Date Received
    March 13, 1998
    Date of Event
    March 12, 1998
    Report Date
    March 13, 1998
    Manufacturer
    MALLINCKRODT CRITICAL CARE
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS BEING INTUBATED AND PILOT BALLOON ON THE ENDOTRACHEAL TUBE COLLAPSED. THERE WERE NO ADVERSE EFFECTS ON THE PT AND ADD'L TUBES WERE AVAILABLE TO USE. TWO TUBES FAILED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT CRITICAL CARE ENDOTRACHEAL TUBE BTR MALLINCKRODT CRITICAL CARE HI-LO TRACHEAL 2 MP04100

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR