BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2893856 · Received January 2, 2013

    Report

    Report Number
    1031452-2013-00012
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE OWNERS MANUAL PART NO 1143482 REV E - 11/09 PROVIDES THE FOLLOWING INFORMATION: THERE ARE MANY DIFFERENT TYPES OF HUMIDIFIERS, OXYGEN TUBING,CANNULAS AND MASKS THAT CAN BE USED WITH THIS DEVICE. YOU SHOULD CONTACT YOUR LOCAL HOME CARE PROVIDER FOR RECOMMENDATIONS ON WHICH OF THESE DEVICES WILL BE BEST FOR YOU. THEY SHOULD ALSO GIVE YOU ADVICE ON THE PROPER USAGE, MAINTENANCE, AND CLEANING. NOTE: UPDATED VERSIONS OF THIS MANUAL CAN BE FOUND AT WWW.INVACARE.COM. INVACARE RECOMMENDS AN ALTERNATE SOURCE OF SUPPLEMENTAL OXYGEN IN THE EVENT OF A POWER OUTAGE, ALARM CONDITION OR MECHANICAL FAILURE. CONSULT YOUR PHYSICIAN OR EQUIPMENT PROVIDER FOR THE TYPE OF RESERVE SYSTEM REQUIRED. THIS EQUIPMENT IS TO BE USED AS AN OXYGEN SUPPLEMENT AND IS NOT CONSIDERED LIFE SUPPORTING OR LIFE SUSTAINING. PLEASE NOTE ANY FURTHER INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A USER FACILITY HAS CALLED TO REPORT THE TUBING IS HOLDING WATER AND THE END USER IS INHALING WATER. THE UNIT HAS BEEN REMOVED AND WAS REPLACED. NO INJURY. THE END USER RESIDES IN A NURSING HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other