BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOX T3, NOXTURNAL

    MDR report key: 5670703 · Received May 20, 2016

    Report

    Report Number
    2021710-2016-03768
    Event Type
    Injury
    Date Received
    May 20, 2016
    Date of Event
    April 21, 2016
    Report Date
    April 21, 2016
    Manufacturer
    NOX MEDICAL
    Product Code
    MNR
    PMA / PMN Number
    K082113
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION FILE IDENTIFICATION: (B)(4). IMPORTER REPORT NUMBER: (B)(4). (B)(4). CAREFUSION 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 ONE OF THEIR PATIENTS COMPLAINED OF A BURNING SENSATION AFTER WEARING THE NONIN 3150 PULSE OXIMETER FOR APPROXIMATELY TWO HOURS DURING AN IN HOME SLEEP STUDY. THE PATIENT REMOVED THE DEVICE AND FOUND THAT THE AREA ON THE PATIENT'S SKIN UNDER WERE THE BATTERIES ARE INSERTED HAD REDNESS AND A BLISTER. THE PATIENT WENT TO URGENT CARE AND WAS TREATED WITH AN ANTIBIOTIC AND A CREAM FOR THE BURN. THE DEVICE WAS RETURNED TO THE CUSTOMER BY THE PATIENT AND THE PATIENT WAS SENT TO A CLINIC FOR THE COMPLETION OF THE SLEEP STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324976 NOX T3, NOXTURNAL VENTILATORY EFFORT RECORDER MNR NOX MEDICAL T3 SLEEP MONITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other NONIN 3150 PULSE OXIMETER (B)(4)