BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 3850191 · Received June 5, 2014

    Report

    Report Number
    3008262382-2014-00063
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 22, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE IRC1705 AEROSOL COMPRESSOR IS RUNNING FOR A WHILE THE UNIT IS NOT PUTTING AS MUCH AIR OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329676 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI INVACARE REHABILITATION EQUIP IRC1705

    Patients

    Seq Age Sex Outcome Treatment
    1 Other