BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASAL ALAR SPO2 SENSOR

    MDR report key: 8512561 · Received April 14, 2019

    Report

    Report Number
    3010150334-2019-00002
    Event Type
    Injury
    Date Received
    April 14, 2019
    Date of Event
    January 3, 2018
    Report Date
    April 14, 2019
    Manufacturer
    XHALE ASSURANCE, INC
    Product Code
    DQA
    UDI-DI
    B213301112140
    PMA / PMN Number
    K171423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DURING IN-SERVICE TRAINING FOR THE PROPER PLACEMENT, SECUREMENT, AND THE NEED TO CHECK AND ROTATE THE SENSOR; A MEMBER OF THE NURSING STAFF REALIZED THAT A SENSOR ON A PATIENT HAD NOT BEEN CHECKED. THE PATIENT WAS EVALUATED AND SKIN UNDER THE SENSOR HAD BECOME VISIBLY PURPLE IN COLOR. THE NURSE SUGGESTED HER BEST GUESS WAS THAT THE SENSOR HAD BEEN IN PLACE FOR SEVERAL DAYS. THE PATIENT WAS RE-EVALUATED LATER IN THE EVENING AND THE SITE HAD TURNED NOTICEABLY DARKER WITH SOME THICKENING OF THE SURFACE. THE RISK MANAGEMENT DEPARTMENT FOR THE HOSPITAL WAS LATER CONTACTED TO OBTAIN ADDITIONAL INFORMATION. THEY WERE UNABLE TO LOCATE ANY REPORTS REGARDING THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE FROM THE HEALTHCARE FACILITY AT THIS TIME. THIS REPORT WILL BE UPDATED IF RELEVANT INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305683 NASAL ALAR SPO2 SENSOR OXIMETER, PROBE DQA XHALE ASSURANCE, INC 301-11214 B213301112140

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention