BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4091908 · Received September 16, 2014

    Report

    Report Number
    3008262382-2014-01072
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ALLEGED THAT THE SIEVE BEDS WERE SATURATED. PER INDEPENDENT REPAIR STATEMENT THE UNIT WAS ALARMING OR RED LIGHT. KEY FAILURE WAS THE SIEVE BEDS WERE SATURATED. ADDITIONAL MALFUNCTIONS WERE THE CHECK VALVE WAS DEFECTIVE, THE PE VALVE HAD A WORN POPPET, AND THE TIE WRAPS AND HOSE CLAMPS WERE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573513 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE REHABILITATION EQUIP IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other