BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 3000718 · Received March 12, 2013

    Report

    Report Number
    1531186-2013-01043
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MEDEL S.P.A.
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4) IT WAS REPORTED BY THE CONSUMER'S MOTHER ALLEGED THAT THE (B)(4) AEROSOL COMPRESSOR WAS INOPERABLE, AND WOULD NOT LOG ON. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103008 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI MEDEL S.P.A. IRC1710

    Patients

    Seq Age Sex Outcome Treatment
    1 9 Other