BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4068405 · Received September 8, 2014

    Report

    Report Number
    3008262382-2014-00921
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Report Date
    August 15, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER THE SIEVE BEDS LEAKING. PER INDEPENDENT REPAIR CENTER STATEMENT THE UNIT HAS LOW O2 OR YELLOW LIGHT. PART NUMBER 1161257 SIEVE BEDS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548442 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE REHABILITATION EQUIP IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other