BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2874241 · Received December 14, 2012

    Report

    Report Number
    3004493922-2012-00698
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CONSUMER STATES ALL SHE WAS TOLD IS THAT IT IS BROKEN, NO DESCRIPTION AS TO HOW OR WHAT IT IS DOING. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE SUZHOU IRC5LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other