BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4101399 · Received September 19, 2014

    Report

    Report Number
    3008262382-2014-01150
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    REPAIR CENTER ALLEGED THE UNIT WAS ALARMING OR RED LIGHT AND KEY IS THE VALVE IS NOT SWITCHING. PER INDEPENDENT REPAIR STATEMENT THE UNIT WAS ALARMING OR RED LIGHT. KEY FAILURE WAS THE 4 WAY VALVE WAS NOT SHIFTING. ADDITIONAL MALFUNCTIONS WERE THE VALVE OPERATOR WAS NOT CYCLING, HOSE CLAMPS WERE LEAKING, AND THE SIEVE BED HAD LOW O2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582098 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE REHABILITATION EQUIP IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other