BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3071742 · Received April 22, 2013

    Report

    Report Number
    1031452-2013-00762
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES THE D/C ADAPTER WENT OUT. PER THE CONSUMER, THE CONCENTRATOR WAS PLUGGED INTO THE CAR WITH D/C ADAPTER AND IT MADE A NOISE AND THE ADAPTER BLEW UP BURNED OUT. NOW IT DOES NOT WORK. (B)(4).

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES THE D/C ADAPTER WENT OUT. PER THE CONSUMER, THE CONCENTRATOR WAS PLUGGED INTO THE CAR WITH D/C ADAPTER AND IT MADE A NOISE AND THE ADAPTER BLEW UP BURNED OUT. NOW IT DOES NOT WORK. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171121 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS XPO140

    Patients

    Seq Age Sex Outcome Treatment
    1 Other