BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2973233 · Received February 21, 2013

    Report

    Report Number
    1031452-2013-00355
    Event Type
    Death
    Date Received
    February 21, 2013
    Date of Event
    January 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). DEATH IS ALLEGED. MALFUNCTION ALLEGED. DATE OF DEATH IS UNKNOWN AT THIS TIME. PROVIDER CALLED IN TO REPORT THAT THEY RECEIVED A CALL FROM (B)(6) THAT THEY HAVE THE UNIT. THE PATIENTS' FAMILY IS ALLEGING NO OXYGEN FLOW. THIS UNIT WAS DELIVERED (B)(6) 2013 AS HER LITER FLOW PRESCRIPTION CHANGED TO A 10 LITER UNIT. PER (B)(6), THE UNIT WAS FULLY TESTED PRIOR TO DELIVERY. UNIT IS BEING RETURNED TO IVC FOR EVALUATION. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75684 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC10LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death