BEUDAMED
    FDA Adverse Event Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 2549264 · Received April 26, 2012

    Report

    Report Number
    1531186-2012-00185
    Date Received
    April 26, 2012
    Date of Event
    April 4, 2012
    Report Date
    April 23, 2012
    Manufacturer
    MEDEL
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED UNIT WAS RUNNING REALLY HOT AND WAS VERY LOUD. RA (B)(4). NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI MEDEL IRC1710

    Patients

    Seq Age Sex Outcome Treatment
    1 Other