BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4093284 · Received September 16, 2014

    Report

    Report Number
    1031452-2014-09498
    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 POPPET KIT VALVE IS NOT SHIFTING, AND THE SIEVE BEDS IS SATURATED THE MUFFLER IS LEAKING, THE WARM CLAMP AND ZIP TIES TUBING ARE LEAKING. NO REPORT OF PATIENT INJURY, NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571629 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other