BEUDAMED
    FDA Adverse Event Death Summary report: N

    EASY CAP

    MDR report key: 29214 · Received December 12, 1995

    Report

    Report Number
    29214
    Event Type
    Death
    Date Received
    December 12, 1995
    Date of Event
    November 5, 1995
    Report Date
    November 13, 1995
    Manufacturer
    NELLCOR-PURITAN BENNET, INC.
    Product Code
    CCK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 82-YR-OLD MALE ADMITTED TO ER ON 11/5/95 COMPLAINING OF DIZZINESS AND EPIGASTRIC PAIN. SHORTLY AFTER ARRIVAL HE SUFFERED A SEIZURE, DEVELOPED RESPIRATORY DISTRESS REQUIRING INTUBATION. CO2 DETECTOR USED TO CHECK TUBE PLACEMENT. FIRST DEVICE DID NOT WORK. SECOND ONE REVEALED CORRECT PLACEMENT OF ET TUBE. WHILE BAGGING WITH AMBU BAG, VENTILATION BECAME DIFFICULT. PT SUSTAINED BILATERAL PNEUMOTHORACES, REQUIRING CHEST TUBES. PT VENTILATING WELL ON VENTILATOR, HOWEVER DIFFICULTY CONTINUED WITH AMBU BAG. IT WAS ULTIMATELY DISCOVERED THAT WHITE PLASTIC CAP HAD BECOME LODGED IN THE EXHALATION VALVE OF THE AMBU BAG. IT IS BELIEVED THAT THE CAP CAME FROM ONE OF THE DEVICES THE PT EXPIRED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY CAP END TIDAL CO2 DETECTOR CCK NELLCOR-PURITAN BENNET, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death