BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4092938 · Received September 16, 2014

    Report

    Report Number
    3008262382-2014-01079
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 25, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    CAW
    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

    PER PROVIDER THE PILOT VALVE IS LEAKING. PER THE INDEPENDENT REPAIR CENTER THE UNIT HAS LOW O2 OR A YELLOW LIGHT. THE PILOT VALVE ON THE MANIFOLD IS LEAKING. THE O RING ON THE MANIFOLD IS DEFECTIVE. THE TIE STRAP ON THE SEIVE BEDS IS DEFECTIVE AND F TUBE ON THE MANIFOLD IS LEAKING. THE TY WRAP ON THE MANIFOLD IS DEFECTIVE AND THE CLAMPS ON THE MANIFOLD ARE DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573158 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE REHABILITATION EQUIP IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other