BEUDAMED
    FDA Adverse Event Death Summary report: N

    EID

    MDR report key: 19562 · Received December 2, 1994

    Report

    Report Number
    19562
    Event Type
    Death
    Date Received
    December 2, 1994
    Date of Event
    October 27, 1994
    Report Date
    December 1, 1994
    Manufacturer
    WOLF TORY MED., INC.
    Product Code
    BTR
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN INTUBATION PROCEDURE A PT DEVELOPED BRADYCARDIA AS TUBE WAS BEING PASSED (ATROPINE GIVEN). PT VENTILATED FOR APPROX 15-20 SECONDS TO STABILIZE BRADYCARDIA, PRIOR TO CONFIRMING INTUBATION WITH DEVICE. PT STABILIZED, BUT LATER ARRESTED. ESOPHAGEAL INTUBATION DISCOVERED IN OR. UNKNOWN: TIME OF ESOPHAGEAL INTUBATION AND RELATIONSHIP TO PT DEATH (VS HEAD INJURY). LARGE AMOUNTS OF AIR IN THE STOMACH ON FIRST X-RAY LED TO SUSPICION OF FALSE POSITIVE DEVICE RESULTS. (NO CO2 DETECTED IN OR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EID ESOPHAGEAL INTUBATION DETECTOR BTR WOLF TORY MED., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death