BEUDAMED
    FDA Adverse Event Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 2884561 · Received December 22, 2012

    Report

    Report Number
    1531186-2012-01863
    Date Received
    December 22, 2012
    Date of Event
    November 12, 2012
    Report Date
    December 22, 2012
    Manufacturer
    MEDEL S.P.A.
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4) - IT WAS REPORTED BY THE CONSUMER THAT THE IRC1710 AEROSOL COMPRESSOR HEAD OF THE NEBULIZER AND THE MASK WAS CRACKED AND HAD A HOLE. 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