BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVOY AER COMPRESSOR 230V UK 9153633106

    MDR report key: 4324323 · Received December 12, 2014

    Report

    Report Number
    1531186-2014-06175
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Report Date
    November 20, 2014
    Manufacturer
    EMG TECHNOLOGY CO. LTD
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE END USER STATES, SHE HAS TO HOLD DOWN THE POWER BUTTON TO GET THE UNIT TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809428 ENVOY AER COMPRESSOR 230V UK 9153633106 COMPRESSOR, AIR, PORTABLE CAF EMG TECHNOLOGY CO. LTD IRC1740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other