BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONC.DEMO UNIT F/IOH2SHOW HFII

    MDR report key: 4811668 · Received June 2, 2015

    Report

    Report Number
    1031452-2015-13981
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Report Date
    May 6, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOR THE PATIENT A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    PER THE INDEPENDENT REPAIR CENTER, THE CUSTOMER ALLEGED PROBLEM IS LOW O2/YELLOW LIGHT AND THE ON/OFF SWITCH WILL NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357007 CONC.DEMO UNIT F/IOH2SHOW HFII GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other