BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONIN MODEL 7500

    MDR report key: 3352879 · Received September 16, 2013

    Report

    Report Number
    2183646-2013-00003
    Event Type
    Death
    Date Received
    September 16, 2013
    Date of Event
    August 28, 2012
    Report Date
    September 13, 2013
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PULSE OXIMETER MODEL 7500 AND THE CAREFUSION VENTILATOR DID NOT ALARM WHEN THE TRACHEOSTOMY TUBE MOVED FAILING TO PROPERLY VENTILATE THE PT, AND THE CAREGIVER WAS NOT AWARE TO RESOLVE THE SITUATION WHICH LED TO THE PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464386 NONIN MODEL 7500 PULSE OXIMETER DQA NONIN MEDICAL, INC. 7500

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Death| R THE PT HAD A TRACHEOSTOMY TUBE,| AND WAS ON A CAREFUSION LTV1200 VENTILATOR