BEUDAMED
    FDA Adverse Event Death Summary report: N

    OHMEDA BIOX

    MDR report key: 595986 · Received April 19, 2005

    Report

    Report Number
    MW4003906
    Event Type
    Death
    Date Received
    April 19, 2005
    Date of Event
    December 1, 2004
    Report Date
    March 15, 2005
    Manufacturer
    OHMEDA
    Product Code
    DQA
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR REQUESTED HELP IN ANALYZING TWO MEDICAL DEVICES THAT MAY BE IMPLICATED IN THE DEATH OF A PT. THEY MENTIONED THAT THEY NEED TO KNOW IF THE ALARM FEATURE ON THE MACHINES WAS WORKING AT THE TIME OF THE DEATH. THE INSTRUMENTS ARE A PULSE OXIMETER BRAND NAME OHMEDA BIOX AND A BREATHING MACHINE BY PULMONETICS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA BIOX PULSE OXIMETER DQA OHMEDA * *
    2 PULMONETICS SYSTEM BREATHING MACHINE CBK PULMONETICS SYSTEM * *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Death