BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINBOW RESPOSABLE ADULT R2-25 SENSOR

    MDR report key: 5019988 · Received August 20, 2015

    Report

    Report Number
    2031172-2015-01030
    Event Type
    Injury
    Date Received
    August 20, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K090165
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SENSOR WAS EVALUATED. DURING EVALUATION, THE SENSOR PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE SENSOR WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. PER THE SENSOR'S DIRECTIONS FOR USE, "THE SITE MUST BE CHECKED FREQUENTLY OR PER CLINICAL PROTOCOL TO ENSURE ADEQUATE CIRCULATION, SKIN INTEGRITY AND CORRECT OPTICAL ALIGNMENT; EXERCISE EXTREME CAUTION WITH POORLY PERFUSED PATIENTS; SKIN EROSION AND PRESSURE NECROSIS CAN BE CAUSED WHEN THE SENSOR IS NOT FREQUENTLY MOVED. ASSESS SITE AS FREQUENTLY AS EVERY (1) HOUR WITH POORLY PERFUSED PATIENTS AND MOVE THE SENSOR IF THERE ARE SIGNS OF TISSUE ISCHEMIA."

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BRUISING/PURPLING OF THE SKIN BELOW THE PATIENT'S CUTICLE WAS FOUND AFTER USING THE R2-25 SENSOR. THE CUSTOMER VOICED CONCERNED OF PRESSURE AREA CARE USING THE R2 SENSOR SYSTEM. THE SENSOR WAS PLACED ON THE RIGHT MIDDLE FINGER OF A (B)(6) MALE PATIENT WITH NORMAL SKIN TISSUE INTEGRITY. THE SENSOR WAS PLACED AT 10:00 AND CHECKED AT 14:00. THIS IS WHEN PURPLING OF THE AREA BELOW THE NAIL WAS FOUND. DURING SURGERY, BOTH ARMS WERE WRAPPED AND CARE WAS TAKEN TO ENSURE NO EXTRA PRESSURE WAS PLACED ON THE SENSOR. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SENSOR WAS PLACED ON THE PATIENT'S FINGER FOR 4 HOURS AND NOT ROTATED AT THE TIME. THERE WAS NO ADDITIONAL TAPE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552275 RAINBOW RESPOSABLE ADULT R2-25 SENSOR OXIMETER DQA MASIMO CORPORATION 24966 A14M728

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other