BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOX T3, NOXTURNAL

    MDR report key: 6028465 · Received October 13, 2016

    Report

    Report Number
    2021710-2016-04638
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    NOX MEDICAL
    Product Code
    MNR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4) IS THE IMPORTER OF RECORD FOR THIS DEVICE. THE LEGAL MANUFACTURER (NOX MEDICAL) HAS BEEN NOTIFIED OF THE REPORTED EVENT. ANY FURTHER REPORTS WILL COME FROM THE LEGAL MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THEIR PATIENT WAS WEARING THE T3 NONIN 3150 PULSE OXIMETER THE PATIENT REPORTED A BUMP AND BURN ON THEIR LEFT FINGER. THE PATIENT HAS NOT BEEN SEEN BY ANY MEDICAL PROFESSIONAL ABOUT THE BURN TO DATE. THE CUSTOMER BELIEVES THAT THEIR PATIENT'S ISSUE WAS DUE TO THE RED LIGHT IN THE FINGER PROBE. THE DEVICE WAS RETURNED TO THE CUSTOMER BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680123 NOX T3, NOXTURNAL VENTILATORY EFFORT RECORDER MNR NOX MEDICAL T3 SLEEP MONITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other NONIN 3150 SOFT SENSOR,MEDIUM, SN: UNKNOWN| T3 NONIN 3150 PULSE OXIMETER, SN: (B)(4)