BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTILATORY CIRCUIT BY INSPIRON

    MDR report key: 19193 · Received November 29, 1994

    Report

    Report Number
    19193
    Event Type
    Death
    Date Received
    November 29, 1994
    Date of Event
    November 21, 1994
    Report Date
    November 28, 1994
    Manufacturer
    SIMS SURGICAL, INC.
    Product Code
    BZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 11/21/94, THIS 67-YR-OLD MALE ON INTERMITTENT VENTILATOR SUPPORT WAS FOUND UNRESPONSIVE AND PULSELESS WITH THE VENTILATOR ALARMING. DESPITE ACLS, THE PT WAS UNABLE TO BE RESUSCITATED. IT WAS NOTED THAT THE VENTILATOR TUBING WAS DISCONNECTED FROM THE HUMIDIFICATION CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATORY CIRCUIT BY INSPIRON VENTILATORY TUBING BZO SIMS SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death