BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS BF-P20D

    MDR report key: 14303 · Received March 24, 1994

    Report

    Report Number
    2429304-1994-00028
    Event Type
    Death
    Date Received
    March 24, 1994
    Date of Event
    March 7, 1994
    Report Date
    March 9, 1994
    Manufacturer
    OLYMPUS OPTICAL CO., LTD.
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 79 YEAR OLD FEMALE PT WAS UNDERGOING A BRONCHOSCOPPY AND HAD BEEN INTUBATED USING THE BRONCHOSCOPE AND ENDOTRACHEAL TUBE. THE BRONCHOSCOPE WAS REMOVED AND A CONCORD/PORTEX SWIVEL OXYGEN ADAPTER WAS CONNECTEED AND TAPED. THE WHITE MEMBRANE OF THE PORTEX ADAPTORR REMAINEED IN PLACE AND THE BRONCHOSCOPE WAS REINSERTED. OXYGEN SATURATION DECREASED TO 84% AND THE PHYSICIAN GAVE ORDERS TO INCREASE THE OXYGEN FLOW RATE. APPROX 30-60 SECONDS LATER, FACIAL EDEMA, ABDOMINAL AND NECK DISTENSION WERE NOTED. THE PHYSICIAN EXTUBATED THE PT. A CHEST X-RAY INDICATED BILATERAL PNEUMOTHORACES. THE PT DID NOT RESPOND TO AGRESSIVE MEDICAL TREATMENT AND FINALLY EXPIRED. THE BRONCHOFIBERSSCOPE WAS EVALUATED BY HOSPITAL PERSONNEL. THE RESULTS AND CONCLUSIONS OF THE EVALUATION INDICATED THAT THERE WERE NO PROBLEMS WITH THE BRONCHOFIBERSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS BF-P20D BRONCHOFIBERSCOPE EOQ OLYMPUS OPTICAL CO., LTD. BF-P20D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death