BEUDAMED
    FDA Adverse Event Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 2873158 · Received December 13, 2012

    Report

    Report Number
    1531186-2012-01741
    Date Received
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    MEDEL S.P.A.
    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

    ON (B)(6) - THE DEALER REPORTED THAT THE IRC1710 AEROSOL COMPRESSOR HAD LOW OUTPUT PRESSURE, AND SUDDENLY STOPPED WORKING. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other