BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4220202 · Received November 3, 2014

    Report

    Report Number
    1031452-2014-17194
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 14, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES, HE PURCHASED 10 UNITS THAT HAVE ALL FAILED. DEALER WAS CONTACTING US TO SEE IF THEY MIGHT BE IMPACTED BY RECALL. THERE WAS ONLY ONE UNIT FROM HIS LOCATION IMPACTED BY THE RECALL. DEALER DID NOT HAVE ANY OF THE SERIAL NUMBERS. DEALER STATES HE HAS ALREADY TAGGED THEM TO GO TO HIS LINCARE REPAIR LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701646 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other