BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONIN 8004CB

    MDR report key: 9276238 · Received November 4, 2019

    Report

    Report Number
    2183646-2019-00001
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    May 20, 2019
    Report Date
    October 10, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO NONIN MEDICAL ON 09OCT2019 AND IS BEING EVALUATED. NONIN HAS BEEN IN DIRECT COMMUNICATION WITH (B)(6) CLINIC (REPORTING SITE) SINCE THE INITIAL REPORT IN JUNE 2019. SENSORS ARE BEING EVALUATED FOR CORRECT FUNCTIONALITY. ADDITIONALLY NONIN REVIEWED LABELING WHICH STATES:"INSPECT THE SENSOR APPLICATION SITE(S) 15 MINUTES AFTER SENSOR APPLICATION AND AT LEAST EVERY 2 TO 4 HOURS TO ENSURE CORRECT SENSOR ALIGNMENT AND SKIN INTEGRITY. PATIENT SENSITIVITY TO THE SENSOR MAY VARY DUE TO MEDICAL STATUS OR SKIN CONDITION".

    Description of Event or Problem · 1

    THIS REPORT IS SUBMITTED BY NONIN MEDICAL INC TO PROVIDE ADDITIONAL INFORMATION TO THE INITIAL REPORT OF MAYO CLINIC ((B)(4)). HEALTH CARE FACILITY REPORTED INJURY TO PATIENT. DESPITE REPEATED REQUESTS FOR DEVICE RETURN, DEVICE ARRIVED TO NONIN MEDICAL 09 OCT 2019 FOR EVALUATION. AT THIS TIME, IT HAS NOT BEEN DETERMINED WHETHER DEVICE FUNCTIONALITY WAS COMPROMISED AT TIME OF USE. DEVICE RETURNED TO NONIN MEDICAL ON 09OCT2019 AND IS BEING EVALUATED. NONIN HAS BEEN IN DIRECT COMMUNICATION WITH (B)(6) (REPORTING SITE) SINCE THE INITIAL REPORT IN JUNE 2019. SENSORS ARE BEING EVALUATED FOR CORRECT FUNCTIONALITY. ADDITIONALLY NONIN REVIEWED LABELING WHICH STATES: "INSPECT THE SENSOR APPLICATION SITE(S) 15 MINUTES AFTER SENSOR APPLICATION AND AT LEAST EVERY 2 TO 4 HOURS TO ENSURE CORRECT SENSOR ALIGNMENT AND SKIN INTEGRITY. PATIENT SENSITIVITY TO THE SENSOR MAY VARY DUE TO MEDICAL STATUS OR SKIN CONDITION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070667 NONIN 8004CB OXIMETER, TISSUE SATURATION MUD NONIN MEDICAL, INC. 8004CB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other