BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORE-SIGHT ELITE TISSUE OXIMETER SENSOR

    MDR report key: 5650154 · Received May 12, 2016

    Report

    Report Number
    2244861-2016-00002
    Event Type
    Injury
    Date Received
    May 12, 2016
    Date of Event
    September 1, 2014
    Report Date
    May 11, 2016
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    MUD
    PMA / PMN Number
    K123700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MFG. DATE UNKNOWN.

    Description of Event or Problem · 1

    A PATIENT AT (B)(6) HOSPITAL EXPERIENCED REDNESS AND MARKS ON HIS FOREHEAD CORRESPONDING TO PLACEMENT OF THE FORE-SIGHT SENSOR. THE NURSE TEAM AT THE HOSPITAL REPORTED THAT IT DID NOT CONSIDER THE MARKS TO CONSTITUTE SERIOUS INJURY, AND THAT THEY CLEARED UP SHORTLY AFTERWARD. INVESTIGATION REVEALED THAT THE DISPOSABLE SENSOR USED ON THE PATIENT WAS CHANGED EVERY 48 HOURS AND WAS NOT ALWAYS APPLIED TO A DIFFERENT ANATOMICAL LOCATION. SUCH USE IS INCONSISTENT WITH THE DIRECTIONS FOR USE FOR THE FORE-SIGHT SENSOR, WHICH STATES THAT THE FACILITY SHOULD ASSESS THE SENSOR SITE AT LEAST EVERY 8 HOURS, OR MORE OFTEN AS REQUIRED BY THE INSTITUTION'S PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305526 FORE-SIGHT ELITE TISSUE OXIMETER SENSOR ELITE SENSOR MUD CAS MEDICAL SYSTEMS, INC. NONE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other