BEUDAMED
    FDA Adverse Event Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 2843115 · Received November 21, 2012

    Report

    Report Number
    1531186-2012-01424
    Date Received
    November 21, 2012
    Report Date
    November 19, 2012
    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

    MDR DECISION DATE: (B)(6) 2012. NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES UNIT WILL NOT START; NO POWER. MDR FILED.

    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. IRC1730

    Patients

    Seq Age Sex Outcome Treatment
    1 Other