BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMS PORTEX

    MDR report key: 406193 · Received July 23, 2002

    Report

    Report Number
    406193
    Event Type
    Death
    Date Received
    July 23, 2002
    Date of Event
    April 14, 2002
    Report Date
    June 17, 2002
    Manufacturer
    SIMS PORTEX INC
    Product Code
    CAI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DIFFICULT VENTILATION NOTED INTRAOPERATIVELY. PT SUBSEQUENTLY ARRESTED. WHEN ANESTHESIA CIRCUIT WAS BYPASSED WITH FREE STANDBY AMBUBAG, VENTILATION (MANUALLY) DID NOT MEET RESISTANCE. THE FILTER IN THE CIRCUIT APPEARED TO BE CLOGGED WITH SECRETIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMS PORTEX ADULT DISPOSABLE BREATHING CIRCUIT CAI SIMS PORTEX INC * 115056 EXP 03/05

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death COUMADIN THERAPY D/C 10/2001.