BEUDAMED
    FDA Adverse Event Death Summary report: N

    BCI

    MDR report key: 528616 · Received June 7, 2004

    Report

    Report Number
    2182466-2004-00001
    Event Type
    Death
    Date Received
    June 7, 2004
    Date of Event
    May 2, 2004
    Report Date
    June 7, 2004
    Manufacturer
    SMITHS MEDICAL PM, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT WAS ON A VENTILATOR AND BEING MONITORED WITH THE PULSE OXIMETER. PT EXPIRED AND DEVICES ALLEGEDLY DID NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BCI PULSE OXIMETER DQA SMITHS MEDICAL PM, INC. 3303 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death