BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASAL ALAR SPO2 SENSOR

    MDR report key: 8771513 · Received July 9, 2019

    Report

    Report Number
    3010150334-2019-00005
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    November 17, 2017
    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
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY HAD TWO PATIENTS THAT HAVE HAD SUSPECTED PRESSURE ISSUES RELATED TO THE SENSOR. COULD NOT CONFIRM THAT SITES WERE BEING ROTATED EVERY 12 HOURS AS RECOMMENDED. 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
    565541 NASAL ALAR SPO2 SENSOR OXIMETER, PROBE, SINGLE USE DQA XHALE ASSURANCE, INC 301-11214

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention