BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DATEX-OHMEDA FLEXSAT SENSOR

    MDR report key: 312939 · Received January 22, 2001

    Report

    Report Number
    9610105-2001-00003
    Event Type
    Injury
    Date Received
    January 22, 2001
    Date of Event
    December 19, 2000
    Report Date
    January 17, 2001
    Manufacturer
    INSTRUMENTARIUM CORP/DATEX-OHMEDA DIV
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUPERFICIAL 2ND DEGREE BURN CAUSED BY FLEXSAT SENSOR SAS-W. THE SENSOR WAS PUT IN PLACE IN LEFT HAND AT THE BABY'S BIRTH UNTIL MOVED TO THE PEDIATRIC DEPT (APPROX AFTER 1 HOUR). MOVED INTO PEDIATRIC WITH THE COMING OUT OF A PHLYCTAENA AT THE SENSOR LOCATION. PHLYCTAENA FACING THE 4TH AND 5TH METATARSAL OF LEFT-HAND (PLANTAR SIDE) 8MM X 7MM.T

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617 DATEX-OHMEDA FLEXSAT SENSOR PULSIOXIMETER MULTISITE SENSOR DQA INSTRUMENTARIUM CORP/DATEX-OHMEDA DIV SAS-W-00-00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Other CARDIOCAP II (CH-RS-43-00).