BEUDAMED
    FDA Adverse Event Death Summary report: N

    INGAGE

    MDR report key: 604437 · Received May 20, 2005

    Report

    Report Number
    1832475-2005-00001
    Event Type
    Death
    Date Received
    May 20, 2005
    Date of Event
    April 26, 2005
    Report Date
    May 20, 2005
    Manufacturer
    FLOTEC, INC.
    Product Code
    CAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WITH ACUTE HEMORRAGIC PANCREATITIS, POLYNEUROPATHY, POST TRACHEOSTEMY, AND RESPIRATORY FAILURE REQUIRING MECHANICAL VENTILATION DIED DURING MRI WHILE BEING SUPPLIED OXYGEN WITH A HAND BAGGING PROCEDURE AT 15 LITERS PER MINUTES FOR 45 MINS.

    Description of Event or Problem · 1

    NI

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INGAGE OXYGEN PRESSURE REGULATOR (868.2700) CAN FLOTEC, INC. DR803-710M1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death