BEUDAMED
    FDA Adverse Event Other Summary report: N

    FNL STROLLER T SF CA M 6LPM

    MDR report key: 1060841 · Received June 12, 2008

    Report

    Report Number
    3004822415-2008-00007
    Event Type
    Other
    Date Received
    June 12, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 10, 2008
    Manufacturer
    CAIRE INC
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A: A REP FROM FACILITY, (REP) HAS BEEN CONTACTED SEVERAL TIMES TO GET SN OF THE UNIT, INFO ABOUT PT AND IF UNIT WILL BE RETURNED TO CAIRE FOR INSPECTION. HOWEVER, THERE IS NO INFO AVAILABLE TO CAIRE AS OF YET. B: CAIRE INC, WILL CONTINUE TO CONTACT FACILITY, FOR FURTHER INFO. THEREFORE AT THIS POINT, NO FURTHER INVESTIGATION WILL BE CONDUCTED BY CAIRE UNLESS OTHERWISE ADVISED BY THE FDA OR UNLESS ADDITIONAL INFO IS RECEIVED THAT WARRANTS FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    VENDOR STATES THAT "WHILE ATTEMPTING TO FILL HER STROLLER (LOX) PT STATED THAT THE UNIT JAMMED AND SHE COULD NOT GET IT TO FILL. WHILE THE STROLLER WAS ATTACHED TO THE LOX BASE UNIT, THE BASE UNIT START SHOOTING LOX OUT OF THE STROLLER CAUSING HER TO RECEIVE 2ND DEGREE BURNS ON HER HANDS AND FINGERS" THE CUSTOMER REFUSED TO RELEASE THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FNL STROLLER T SF CA M 6LPM STROLLER (PORTABLE) BYJ CAIRE INC 10564125

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other