BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3974793 · Received August 4, 2014

    Report

    Report Number
    1031452-2014-05028
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    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

    CUSTOMER FORWARDED A SPREADSHEET WITH MULTIPLE UNITS WITH VARIOUS ISSUES. SPECIFIC DETAILS TO THE SYMPTOM OF THE PRODUCT NOT AVAILABLE. SPREADSHEET ONLY DETAILS WHICH PART WAS REPLACED. THIS ONE THEY REPLACED THE PILOT VALVE. ONLY OTHER NOTE WAS THAT THE UNIT WAS SHUTTING DOWN PER THE TBM IN THE EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453357 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other