BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVOY AER COMPRESSOR 230V AUS 9153632953

    MDR report key: 4339513 · Received December 18, 2014

    Report

    Report Number
    1531186-2014-06426
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Report Date
    November 25, 2014
    Manufacturer
    PHILIPS/RESPIRONICS NEW JERSEY INC.
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER IS REPORTING THE DEVICE HAS LOW PRESSURE OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830801 ENVOY AER COMPRESSOR 230V AUS 9153632953 COMPRESSOR, AIR, PORTABLE BTI PHILIPS/RESPIRONICS NEW JERSEY INC. IRC1710

    Patients

    Seq Age Sex Outcome Treatment
    1 Other