BEUDAMED
    FDA Adverse Event Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 3090618 · Received May 2, 2013

    Report

    Report Number
    1531186-2013-01884
    Date Received
    May 2, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDEL S.P.A.
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH AN IRC1710 AEROSOL COMPRESSOR THAT WILL NOT TURN ON. THIS ISSUE COULD CAUSE A USER TO MISS THEIR PRESCRIBED DOSE OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192861 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI MEDEL S.P.A. IRC1710

    Patients

    Seq Age Sex Outcome Treatment
    1 Other