BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONIN AVANT MODEL 9600

    MDR report key: 2097563 · Received May 12, 2011

    Report

    Report Number
    2183646-2011-00002
    Event Type
    Death
    Date Received
    May 12, 2011
    Date of Event
    June 12, 2010
    Report Date
    May 12, 2011
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED INDICATING THAT AN AVANT 9600 PULSE OXIMETER SYSTEM ALLEGEDLY DID NOT ALARM WHILE MONITORING A PT ON VENTILATOR SUPPORT. IT IS ALLEGED THAT THE VENTILATOR (NOT MANUFACTURED BY NONIN) ALSO DID NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONIN AVANT MODEL 9600 PULSE OXIMETER DQA NONIN MEDICAL, INC. 9600

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Death THERE WAS A VENTILATOR ALSO ATTACHED TO THE PT.