BEUDAMED
    FDA Adverse Event Summary report: N

    THERMOMETER PROBE

    MDR report key: 18636 · Received December 30, 1994

    Report

    Report Number
    MW1004606
    Date Received
    December 30, 1994
    Report Date
    December 28, 1994
    Manufacturer
    HOSPITAK, INC.
    Product Code
    FLL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE T-PIECE OF AN IN-LINE SUCTION CATHETER WAS PLACED ON TOP OF THE THERMOMETER. THE THERMOMETER CAP LODGED IN THE T-PIECE AND WHEN THE T-PIECE WAS RECONNECTED TO THE VENTILATOR CIRCUIT, THE CAP COMPLETELY OCCLUDED THE CIRCUIT, CAUSING FAILURE OF AIRFLOW TO THE PT. THE VENTILATOR ALARMED. THE RPTR WAS ABLE TO DUPLICATE THE INCIDENT. THE RPTR STATED THAT, ALTHOUGH IT TOOK A LITTLE FORCE TO GET THE CAP INTO THE T-PIECE, HE FEELS THAT THE CAP SHOULD NOT BE THE SAME SIZE AS THE T-PIECE, SHOULD BE OPAQUE INSTEAD OF CLEAR SO THAT IT CAN BE SEEN EASILY, AND SHOULD NOT BE CYLINDRICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOMETER PROBE FLL HOSPITAK, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 *