BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVOY AER COMPRESSOR 230V AUS 9153632953

    MDR report key: 4374834 · Received December 31, 2014

    Report

    Report Number
    1531186-2014-07050
    Event Type
    Malfunction
    Date Received
    December 31, 2014
    Report Date
    December 10, 2014
    Manufacturer
    EMG TECHNOLOGY CO. LTD
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES UNIT HAS WEAK AIR FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861564 ENVOY AER COMPRESSOR 230V AUS 9153632953 COMPRESSOR, AIR, PORTABLE BTI EMG TECHNOLOGY CO. LTD IRC1740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other