BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENFLOW

    MDR report key: 2092883 · Received May 11, 2011

    Report

    Report Number
    3006095475-2011-00001
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ENGINIVITY LLC
    Product Code
    LGZ
    PMA / PMN Number
    K060537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT WERE NOT RELEASED BY THE SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ENFLOW FLUID WARMER WAS PLACED NEXT TO A PATIENT'S RIGHT FOREARM WITH A SINGLE SHEET IN BETWEEN DURING SURGERY. THE SURGERY LASTED FROM 07:30 TO APPROXIMATELY 12:30. A SECOND DEGREE BURN WAS NOTED ON THE RIGHT ARM WHEN THE PATIENT WAS MOVED FROM THE SURGERY BED TO THE STRETCHER FOR TRANSPORT. THE BURN WAS INSPECTED BY DR (B)(6) FROM ANESTHESIA AND IT WAS DETERMINED THAT NO INTERVENTION WAS REQUIRED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENFLOW THERMAL INFUSION FLUID WARMER LGZ ENGINIVITY LLC 980105VS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other