BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONIN MODEL 7500

    MDR report key: 3631825 · Received February 4, 2014

    Report

    Report Number
    2183646-2014-00001
    Event Type
    Death
    Date Received
    February 4, 2014
    Date of Event
    March 6, 2013
    Report Date
    February 4, 2014
    Manufacturer
    NONIN MEDICAL INC
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE (B)(6) OLD, DIED ON (B)(6) 2013 AS THE DIRECT RESULT OF A COMPLETION OCCLUSION OF HER TRACHEOSTOMY TUBE. THE RESPIRATORY MONITOR FAILED TO ALARM THAT THE PT'S HEART RATE AND BREATHING HAD SLOWED AS A RESULT OF THE OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73798 NONIN MODEL 7500 PULSE OXIMETER DQA NONIN MEDICAL INC 7500

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Death| R TRACHEOSTOMY TUBE