BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL ALAR SP02 SENSOR

    MDR report key: 9732060 · Received February 20, 2020

    Report

    Report Number
    9732060
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    January 23, 2020
    Report Date
    February 17, 2020
    Manufacturer
    XHALE ASSURANCE, INC.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SKIN BREAKDOWN (BURN VS. PRESSURE-RELATED BREAKDOWN) NOTED AT PATIENT NARE WHERE PULSE OXIMETRY SENSOR DEVICE HAD BEEN IN PLACE. SIMILAR SKIN BREAKDOWN NOTED IN A SECOND PATIENT IN A DIFFERENT ICU LOCATION. BOTH PATIENTS IN CRITICAL CARE SETTINGS WITH VASOPRESSOR(S) INFUSION REQUIREMENTS. SUSPECT POSSIBLE ISSUE WITH STAFF NOT ROTATING THE PROBE SITE AS FREQUENT AS PER MANUFACTURER RECOMMENDATIONS FOR PATIENTS AT HIGH RISK OF SKIN BREAKDOWN. MORE EDUCATION IS LIKELY WARRANTED. RECOMMENDATIONS FROM MANUFACTURER HAVE BEEN (FOR HIGH RISK POPULATION) TO ROTATE SITE EVERY 4 HOURS AND ASSESS SITE AT LEAST EVERY 2 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197783 NASAL ALAR SP02 SENSOR OXIMETER DQA XHALE ASSURANCE, INC. 301-11214

    Patients

    Seq Age Sex Outcome Treatment
    1 26645 DA Other