BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASAL ALAR SPO2 SENSOR

    MDR report key: 8772589 · Received July 9, 2019

    Report

    Report Number
    3010150334-2019-00009
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    February 27, 2018
    Report Date
    July 9, 2019
    Manufacturer
    XHALE ASSURANCE, INC
    Product Code
    DQA
    PMA / PMN Number
    K171423
    Removal / Correction Number
    3010150334-50819-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTED THAT THE SENSOR HAD CAUSED SKIN BREAKDOWN ON A VERY SICK HIGH-RISK PATIENT. THE SENSOR IN QUESTION WAS DISCARDED AND UNABLE FOR EVALUATION. THE CUSTOMER STATED THE SENSOR WAS BEING ROTATED EVERY FOUR HOURS. THERE IS NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WILL BE UPDATED IF RELEVANT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564819 NASAL ALAR SPO2 SENSOR OXIMETER, PROBE, SINGLE USE DQA XHALE ASSURANCE, INC 301-11214

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention