BEUDAMED
    FDA Adverse Event Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 2955869 · Received February 11, 2013

    Report

    Report Number
    1531186-2013-00512
    Date Received
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MEDEL S.P.A.
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(6) -THE DEALER REPORTED THAT THE IRC1700 AEROSOL COMPRESSOR HAD LOW OUTPUT PRESSURE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58434 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI MEDEL S.P.A. IRC1700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other