BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVOY AER COMPRESSOR 230V AUS 9153632953

    MDR report key: 4341833 · Received December 18, 2014

    Report

    Report Number
    1531186-2014-06514
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 5, 2014
    Manufacturer
    RESPIRONICS INC
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY A PROVIDER THAT AN (B)(4) AEROSOL COMPRESSOR WILL NOT TURN ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831461 ENVOY AER COMPRESSOR 230V AUS 9153632953 COMPRESSOR, AIR, PORTABLE CAF RESPIRONICS INC IRC1710

    Patients

    Seq Age Sex Outcome Treatment
    1 Other