BEUDAMED
    FDA Adverse Event Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 3806024 · Received May 12, 2014

    Report

    Report Number
    1531186-2014-01755
    Date Received
    May 12, 2014
    Report Date
    April 8, 2014
    Manufacturer
    EMG TECHNOLOGY CO. LTD
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE ON OFF SWITCH ON AN (B)(4) TEDDY BEAR PEDIATRIC AEROSOL COMPRESSOR IS LOOSE CAUSING INTERMITTENT OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284720 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI EMG TECHNOLOGY CO. LTD IRC1740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other