BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3146032 · Received June 4, 2013

    Report

    Report Number
    1031452-2013-01047
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Report Date
    May 7, 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

    (B)(4) ISSUED MFR. REPORT # 1031452-2013-01047 INDICTING THE MANUFACTURER AS INVACARE - (B)(4) WHEN THE ACTUAL MANUFACTURER IS INVACARE (B)(4).

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE CONCENTRATOR SHUT DOWN UNEXPECTEDLY. IT IS UNKNOWN IF THE UNIT ALARMED PRIOR TO SHUTTING DOWN TO ALERT THE USER TO SWITCH TO AN ALTERNATE SOURCE OF OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245957 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other