BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONIN 8004CB

    MDR report key: 9278871 · Received November 5, 2019

    Report

    Report Number
    2183646-2019-00002
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    March 26, 2019
    Report Date
    November 5, 2019
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    MUD
    PMA / PMN Number
    K113215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SENSOR WAS USED WITH A COMPATIBLE NONIN SENSMART OXIMETRY SYSTEM. HOWEVER, 2 OF THE 4 SENSORS WERE INVOS (MANUFACTURED BY MEDTRONIC). NONIN HAS NOT CONDUCTED TESTING FOR COMPATIBILITY OF THE SENSMART SYSTEM WITH THE INVOS DEVICE. IT HAS NOT BEEN DETERMINED IF THESE DEVICES (INVOS AND 8004CB) CAN BE USED CONCURRENTLY. THE LABELING OF SENSSMART INDICATES THAT THE SYSTEM SHOULD ONLY BE USED WITH COMPATIBLE NONIN SENSORS. DEVICE WAS EVALUATED AT ADVOCATE CHILDREN'S HOSPITAL BY (B)(4) PERSONNEL ON 16 APR 2019. ON-SITE TEMPERATURE MEASUREMENTS DID NOT INDICATE NOR RAISE A SUSPICION OF A POTENTIAL FOR A HEAT RELATED BURN. FUNCTIONAL TESTING SHOWED FAILURE OF SENSOR - EVALUATORS DETERMINED THAT THIS MAY BE A RESULT OF THE STORAGE METHOD USED WHILE AWAITING TESTING AND EVALUATION. NOTE: DATA OBTAINED DURING THE OR PROCEDURE PROVIDED EVIDENCE THAT THE SENSOR WAS OPERATIONAL AND PROVIDING RSO2 READINGS DURING IT.

    Description of Event or Problem · 1

    SENSMART SYSTEM WAS BEING EVALUATED BY ADVOCATE CHILDREN'S HOSPITAL FOR USE IN ITS FACILITY APPROXIMATELY ONE MONTH PRIOR TO THE INCIDENT. THE PATIENT WAS MONITORED FROM (B)(6) 2019 USING FOUR (4) SENSORS - TWO ON THE FOREHEAD AND TWO ON THE BACK. THE SENSORS WERE PLACED ON INTACT SKIN. THE SENSOR(S) HAD BEEN IN PLACE FOR 24 HOURS. DURING THIS TIME, TWO SMALL PINPOINT SUPERFICIAL WOUNDS DEVELOPED ON THE FOREHEAD. EACH APPROXIMATELY 0.2CM X 0.2CM. NOTE: PRIOR TO REMOVAL OF THE SENSOR THAT IS THE SUBJECT OF THIS REPORT, IT WAS NOTED THAT THE PATIENT HAD GENERALIZED EDEMA. PATIENT INJURY WAS TREATED BY WITH SILVADENE AND COVERED WITH MEPILEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076235 NONIN 8004CB OXIMETER, TISSUE SATURATION MUD NONIN MEDICAL, INC. 8004CB

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA Other