BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELIOS RESERVOIR

    MDR report key: 4638086 · Received March 26, 2015

    Report

    Report Number
    3004822415-2015-00006
    Event Type
    Injury
    Date Received
    March 26, 2015
    Date of Event
    September 3, 2012
    Report Date
    March 25, 2015
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K860937
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED OF AN ALLEGED INCIDENT ON (B)(6) 2015. THE ALLEGED INCIDENT WAS DESCRIBED TO THE COMPANY AS THE FOLLOWING. "WHILE THE PT WAS FILLING THE PORTABLE, THE QDV FROZE. LOX SPILLED OVER AND SOAKED THE PT'S SOCKS CAUSING 2ND AND 3RD DEGREE BURNS TO HER FOOT." THE COMPANY IS CURRENTLY INVESTIGATING THE ALLEGED INCIDENT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADD'L INFO IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204314 HELIOS RESERVOIR UNIT, LIQUID OXYGEN, BASE, RESERVOIR BYJ CAIRE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other