BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4130179 · Received September 30, 2014

    Report

    Report Number
    3008262382-2014-01368
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 11, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ADVISED RECEIVED BACK FROM (B)(4) AND STILL HAVING THE SAME ISSUE PURITY IS FLUCTUATING FROM 81 PERCENT TO 85 PERCENT WITH AMBER LIGHT , NO INJURY, DEALER COULD NOT PROVIDE ANY FURTHER INFORMATION...(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607362 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE REHABILITATION EQUIP IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other