BEUDAMED
    FDA Adverse Event Other Summary report: N

    O2 LIQUID PORTABLE UNIT

    MDR report key: 1051764 · Received May 21, 2008

    Report

    Report Number
    3004822415-2008-00005
    Event Type
    Other
    Date Received
    May 21, 2008
    Date of Event
    July 25, 2007
    Report Date
    May 2, 2008
    Manufacturer
    CAIRE INC
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A: THE STROLLER UNIT DID NOT PRODUCE THE ISSUES REPORTED TO CAIRE DURING ENGINEERING TESTING. THE NUMEROUS CRACKS, FRACTURES AND ABRASIONS ON THE STROLLER CASE ARE SIGNS OF ROUGH HANDLING. SOME FORM OF AN ADHESIVE HAS BEEN APPLIED TO THE UNIT IN AN ATTEMPT TO FIX THE FRACTURES AND CRACKS. THE DISTRIBUTOR HAS BEEN ADVISED NOT TO USE THE UNIT.

    Description of Event or Problem · 1

    PT/VENDOR STATES THAT: IN 2007, THE MOTHER REPORTED HER SON SUFFERED BURNS TO HIS FACE AND AROUND HIS EARS WHERE THE CANNULA TOUCHED HIS SKIN. THEY WENT TO THE EMERGENCY ROOM FOR TREATMENT. THE MOTHER HAS RETURNED THE EQUIPMENT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O2 LIQUID PORTABLE UNIT STROLLER 1.2 BYJ CAIRE INC 10564109

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other