BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STROLLER PORTABLE OXYGEN CONTAINER

    MDR report key: 949349 · Received November 13, 2007

    Report

    Report Number
    MW5004428
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    November 13, 2007
    Report Date
    November 13, 2007
    Manufacturer
    CAIRE, INC
    Product Code
    BYJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EMERGENCY ALERT- SECOND PRODUCT INCIDENT WITH OXYGEN DEVICE IN OUR NURSING HOME!!! THIS REPORTER SUBMITTED A FIRST INCIDENT FDA MEDWATCH REPORT ONLINE NOV 2 AND ADDENDUM NOV 7, 2007. REPORTER REC'D EMAIL CONFIRMATION NOV 7 FROM FDA MEDWATCH. SECOND INCIDENT WHEREBY PORTABLE OXYGEN CANNISTER-STROLLER PORTABLE MODEL LIQUID OXYGEN CONTAINER; MFR IS CAIRE INC.//CHART INDUSTRIES. TODAY, SECOND INCIDENT INVOLVING USE OF THIS PRODUCT - EXACT MODEL AND TYPE AS ONE NOTED NOV 1/NOV 7, 2007 REPORT TO FDA!!. PRODUCT STARTED TO ICE UP OXYGEN TUBING WHILE BEING USED TO GIVE OXYGEN TO NURSING HOME PT. STAFF IMMEDIATELY OBSERVED DANGER TO PATIENT AND IMMEDIATELY TERMINATED USE OF DEVICE. CONCERN IS SIGNIFICANT SAFETY RISK FOR NURSING HOME PATIENTS IN USING THIS DEVICE; AND LACK OF FOLLOW THRU BY SUPPLIER AND DISTRIBUTER AMERICAS BEST/LINCARE CO.; AND NO RESPONSE TO DATE BY MFR CAIRE INC, OF MARIETTA GEORGIA, OWNED BY CHART INDUSTRIES OF BURNSVILLE, MN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other