BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 3011868 · Received March 19, 2013

    Report

    Report Number
    3004493922-2013-00632
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 19, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE NEBULIZER STOPPED WORKING WHICH COULD CAUSE THE USER TO MISS PRESCRIBED DOSE(S) OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113894 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI INVACARE SUZHOU IRC1705

    Patients

    Seq Age Sex Outcome Treatment
    1 3 Other