BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4093453 · Received September 16, 2014

    Report

    Report Number
    1031452-2014-09532
    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
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER ALLEGED POWER SWITCH HAS A SHORT CIRCUIT. PER INDEPENDENT REPAIR CENTER STATEMENT, THE UNIT WAS ALARM WILL NOT FUNCTION. THE KEY FAILURE WAS POWER SWITCH HAS A SHORT CIRCUIT. ADDITIONAL MALFUNCTIONS WERE 10L TOP END REBUILD ON COMPRESSOR WAS LOW OUTPUT AND INLET FILTER ON SOUND BOX WAS THE WRONG TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571524 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC10LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other