BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4092912 · Received September 16, 2014

    Report

    Report Number
    1031452-2014-09469
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 25, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PROVIDER THAT THE VALVE IS STUCK. PER INDEPENDENT REPAIR CENTER STATEMENT: THE UNIT IS ALARMING OR RED LIGHT. THE REXROTH VALVE IS STUCK, THE POPPIT VALVE NOT SHIFTING, THE TY WRAPS TUBING IS LEAKING AND THE PE VALVE IS NOT SHIFTING. NO PATIENT INJURY ALLEGED, NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573590 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other