BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONIN

    MDR report key: 1435797 · Received August 7, 2009

    Report

    Report Number
    2183646-2009-00003
    Event Type
    Other
    Date Received
    August 7, 2009
    Date of Event
    July 6, 2009
    Report Date
    August 6, 2009
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    PMA / PMN Number
    K002690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUCTIONS FOR USE CAUTIONS OPERATOR TO INSPECT THE SENSOR APPLICATION SITE AT LEAST EVERY 6-8 HOURS TO ENSURE CORRECT SENSOR ALIGNMENT AND SKIN INTEGRITY. PT SENSITIVITY TO SENSORS MAY VARY DUE TO MEDICAL STATUS OR SKIN CONDITION. THE 8000AA SENSOR IS DESIGNED FOR SPOT CHECKING OR DATA COLLECTION OF ADULT OR ADOLESCENT PTS, WHERE LITTLE SENSOR MOTION IS EXPECTED. ADDITIONAL MODEL# 8000AA.

    Description of Event or Problem · 1

    AS STATED BY PT: PT WOKE UP DUE TO "SPARKING" AND SHUT OFF UNIT AND REMOVED IT FROM HIS FINGER DUE TO A "BURN" ON HIS FINGER. AS STATED BY JANICE SANDOVAL - RESPIRATORY THERAPIST: SHE DID NOT SEE THE PT'S FINGER AND THE DATA DOES NOT MATCH HIS DESCRIPTION. SHE ALSO STATED THERE WERE NO SIGNS OF THERMAL DAMAGE TO SENSOR OR UNIT. PT DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONIN 920MP PULSE OXIMETER AND 8000AA SENSOR DQA NONIN MEDICAL, INC. 920MP 8000AA - 0823

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other