BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5LTR PLAT CONC W/SESO2 AND HFIIC 9153629597

    MDR report key: 5116160 · Received October 1, 2015

    Report

    Report Number
    1031452-2015-16127
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Report Date
    September 3, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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

    DEALER CALLED FOR A PC BOARD ON AN OLD 5LX NON-PLATINUM MACHINE, STATING THERE IS NO ALARM WHEN THE O2 IS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649823 5LTR PLAT CONC W/SESO2 AND HFIIC 9153629597 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1