BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASAL ALAR SPO2 SENSOR

    MDR report key: 8772337 · Received July 9, 2019

    Report

    Report Number
    3010150334-2019-00007
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    January 12, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPANY WASMADE AWARE BY ONE OF THE RESIDENTS THAT THE SENSOR IS CAUSING SKIN BREAKDOWN ON PATIENTS. THREE PATIENTS WERE OBSERVED WHERE THE WOUNDS ARE NOW APPROXIMATELY 2-3 WEEKS OLD AND ARE HEALING YET STILL QUITE VISIBLE WITH BLACK SCABS AND ITS TOO SOON TO TELL IF IT WILL LEAVE SCARRING. THE SENSOR IS JUST NOW BEING IMPLEMENTED THROUGHOUT THE ICU'S (PREVIOUSLY CAME IN THROUGH THE ED AND AT TIMES ICU STAFF WAS ABLE TO STEAL SOME FROM THE ED). 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
    567590 NASAL ALAR SPO2 SENSOR OXIMETER, PROBED, SINGLE USE DQA XHALE ASSURANCE, INC 301-11214

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention