BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2973231 · Received February 21, 2013

    Report

    Report Number
    1031452-2013-00361
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). INJURY ALLEGED. MALFUNCTION ALLEGED. CONSUMER ALLEGES THE CONCENTRATOR STARTED BEEPING LOW 02. SHE SAID HER LIPS TURNED PURPLE, HER NAILS TURNED PURPLE. MEDICAL INTERVENTION SOUGHT. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75653 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS XPO100B

    Patients

    Seq Age Sex Outcome Treatment
    1 65 Hospitalization