BEUDAMED
    FDA Adverse Event Other Summary report: N

    LNCS INF ADHESIVE SENSOR

    MDR report key: 3843794 · Received May 23, 2014

    Report

    Report Number
    2031172-2014-00047
    Event Type
    Other
    Date Received
    May 23, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K120657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SENSOR BEING USED AT THE TIME OF THE REPORTED EVENT WAS DISCARDED. THE DEVICE HISTORY RECORDS (DHRS) FOR THE SENSOR USED WERE REVIEWED WITH SPECIFIC ATTENTION ON THE RAW MATERIALS, THE SUBASSEMBLY PROCESS, THE MANUFACTURING PROCESS AND PRODUCT TESTING. THIS DEVICE MET ALL CRITERIA FOR FINAL PRODUCT RELEASE. NOTHING WAS IDENTIFIED IN THE DHR TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. ACCORDING TO THE USER FACILITY "THE PATIENT HEALED WITHOUT ANY MEDICAL INTERVENTION". PER THE DIRECTIONS FOR USE, "FOR FRAGILE SKIN, THE STICKINESS OF THE MEDICAL GRADE ADHESIVE CAN BE DIMINISHED OR ELIMINATED BY DAUBING THE ADHESIVE AREAS WITH A COTTON BALL OR WITH GAUZE." MASIMO CLINICAL SPECIALISTS HAVE WORKED WITH THE CUSTOMER TO PROVIDE ADDITIONAL EDUCATION REGARDING SENSOR USE. IN ADDITIONAL, THE CUSTOMER HAS BEEN PROVIDED ADDITIONAL INFORMATION REGARDING LOW-ADHESIVE AND NO-ADHESIVE SENSORS AS REQUESTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE CUSTOMER: "WE CURRENTLY USE THE DISPOSABLE SPO2 PROBES ON OUR AVEA VENTILATORS WITH CLIO2. RECENTLY, WHEN REMOVING THE PROVE, THERE WAS SOME BLEEDING THAT OCCURRED. THEY ARE VERY STICKY." THE CUSTOMER ALSO REQUESTED "ALTERNATIVE OPTIONS" TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307975 LNCS INF ADHESIVE SENSOR DQA MASIMO CORPORATION LNCS INF K14ARR

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other