BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONIN

    MDR report key: 8678428 · Received June 7, 2019

    Report

    Report Number
    8678428
    Event Type
    Injury
    Date Received
    June 7, 2019
    Date of Event
    May 20, 2019
    Report Date
    May 31, 2019
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    MUD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS RECEIVING OXIMETRY MONITORING WITH THE NONIN SENSMART SYSTEM. PATIENT BECAME DIAPHORETIC AND THE SENSORS WERE NOT FUNCTIONING. SENSORS WERE REMOVED AND NEW SENSORS WERE PLACED. WHEN THE NEW SENSORS WERE REMOVED, IT WAS IDENTIFIED THAT THE PATIENT HAD 3 CIRCULAR BURNS ON THE FOREHEAD WHERE THE SENSORS WERE LOCATED. WOUNDS ARE BEING TREATED WITH ULTRASONIC MIST THERAPY, ULTRASOUND, DEBRIDEMENT AND OTHER WOUND CARES. WOUNDS ARE JUST UNDER 1 CM IN DIAMETER EACH. MANUFACTURER RESPONSE FOR NEONATAL/PEDIATRIC SENSOR, NONIN (PER SITE REPORTER): UNKNOWN. CLINICAL NURSE SPECIALIST (CNS) CONTACTED NONIN REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471782 NONIN OXIMETER, TISSUE SATURATION MUD NONIN MEDICAL, INC. 8004CB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention