BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONIN MODEL 8004CB

    MDR report key: 3978816 · Received July 1, 2014

    Report

    Report Number
    2183646-2014-00002
    Event Type
    Other
    Date Received
    July 1, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 27, 2014
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL CAUSES FOR THIS ALLEGED INCIDENT ARE LABELLED FOR IN OUR INSTRUCTIONS FOR USE. THE INSTRUCTIONS MAY NOT HAVE BEEN FOLLOWED RESULTING IN THE ALLEGED INCIDENT. FACTORS THAT MAY DEGRADE PERFORMANCE OR AFFECT THE ACCURACY OF THE MEASUREMENT INCLUDE THE FOLLOWING: ELECTROSURGICAL INTERFERENCE.

    Description of Event or Problem · 1

    NURSES FOUND A LITTLE DARK AREA UPON SENSOR REMOVAL "BLACKENED" MARK. REPORTED AS POSSIBLE PRESSURE SORE, ON PATIENT WHO UNDERWENT CARDIAC SURGERY THE PREVIOUS DAY. THE ''BOVIE PAD' WAS PLACED OVER OR VERY NEAR THE SENSOR ACCORDING TO A HOSPITAL OBSERVER. SENSOR WAS LEFT IN PLACE FOR MORE THAN 12 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385453 NONIN MODEL 8004CB OXIMETER DQA NONIN MEDICAL, INC. 8004CB 32793

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR POSSIBLY BOVIE ELECTRO SURGICAL GENERATOR