BEUDAMED
    FDA Adverse Event Other Summary report: N

    PURELIGHT SENSOR

    MDR report key: 1070844 · Received July 1, 2008

    Report

    Report Number
    2183646-2008-00002
    Event Type
    Other
    Date Received
    July 1, 2008
    Date of Event
    June 3, 2008
    Report Date
    July 1, 2008
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    PMA / PMN Number
    K893221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    AS REPORTED BY A HOME CARE REPRESENTATIVE "...A PATIENT'S MOTHER WENT TO CHANGE THE PROBE THAT MORNING AND FOUND EXPOSED WIRES AND A BURN ON PATIENT'S TOE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PURELIGHT SENSOR PULSE OXIMETER SENSOR DQA NONIN MEDICAL, INC. 7000 A NOT SPECIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK