BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 3884415 · Received June 19, 2014

    Report

    Report Number
    3008262382-2014-00112
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 21, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    END USER'S MOTHER STATED THE UNIT IS NOT BLOWING OUT AS IT USED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361924 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI INVACARE REHABILITATION EQUIP IRC1710

    Patients

    Seq Age Sex Outcome Treatment
    1 Other