BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORE-SIGHT ELITE TISSUE OXIMETER SENSOR(S)

    MDR report key: 7134101 · Received December 20, 2017

    Report

    Report Number
    2244861-2017-00002
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 20, 2017
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    MUD
    UDI-DI
    10609538711012
    PMA / PMN Number
    K143675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER WENT OFF-LABEL NOT CHECKING THE SENSOR SITE AT THE RECOMMENDED INTERVALS. FROM PHOTO EVIDENCE IT IS APPARENT THAT TWO SIZES OF SENSORS WERE USED TOGETHER WHICH IS NOT A TYPICAL PRACTICE AND ONE OF THOSE WAS USED INCORRECTLY BY THE IFU. ALSO, PHOTO EVIDENCE SHOWS THE DELIVERY OF LASIX INDICATING A TREATMENT FOR EDEMA, WHICH THE IFU CAUTIONS TO BE AWARE OF SO AS NOT TO OVER TIGHTEN THE SENSOR HOLDING HEADBAND AND POSSIBLY CREATING AN OVER PRESSURE INJURY.

    Description of Event or Problem · 1

    A PATIENT THAT HAD OPEN HEART SURGERY WAS RECOVERING WHEN, AFTER 48 HOURS OF CEREBRAL OXIMETRY MONITORING, THE SENSOR SITE WAS CHECKED TO FIND REDNESS AND SWELLING ON THE FOREHEAD AND UNDER THE APPLICATION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915371 FORE-SIGHT ELITE TISSUE OXIMETER SENSOR(S) CEREBRAL OXIMETER SENSOR MUD CAS MEDICAL SYSTEMS, INC. SMALL AND NON ADHESIVE SMALL 2016-22, 2016-41 10609538711012

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other LASIX