BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAIRE STROLLER PORTABLE

    MDR report key: 1658052 · Received April 13, 2010

    Report

    Report Number
    3004822415-2010-00003
    Event Type
    Injury
    Date Received
    April 13, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 18, 2010
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT HAS NOT BEEN RETURNED TO CAIRE INC. FOR EVAL. THE UNIT IS TO BE SHIPPED BACK ON APRIL 7, 2010. THE UNIT WILL BE EVALUATED AND A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY RCS THAT A STROLLER UNIT WAS PLACED ON A PT. THE PT WAS IN A NURSING HOME IN (B) (6). AFTER SOME TIME, FROST WAS OBSERVED ON THE CANNULA AND THE PT REC'D BURNS ON THE UPPER LIP AND NOSE. SOMEONE ELSE REMOVED THE CANNULA. THE PT WAS TAKEN TO THE ER FOR EVAL. RCS DID NOT BELIEVE THE INJURIES TO BE EXTENSIVE. THERE WERE RED MARKS ABOVE THE LIPS. THE PT WAS RELEASED FROM THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAIRE STROLLER PORTABLE BYJ UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE, INC. STROLLER PORTABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention