BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEBULIZERS TO DELIVER AEROSOLS

    MDR report key: 2013069 · Received March 1, 2011

    Report

    Report Number
    1525712-2011-00071
    Event Type
    Other
    Date Received
    March 1, 2011
    Date of Event
    February 4, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MEDEL S.P.A.
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEALER ALLEGES THE PRODUCT WAS OVER HEATING WHEN TURNED ON, AND THE DEALER REPLACED THE UNIT FOR THE CONSUMER. PRODUCT WAS RETURNED FOR REGULATORY AFFAIRS INSPECTION. VISUAL INSPECTION: THE AEROSOL COMPRESSOR HAD METAL FRAGMENTS UNDER THE COMPRESSOR. THE FUNCTIONAL TESTING SHOWED NO DISCREPANCIES. DEVICE ALLEGEDLY OVERHEATED WHEN TURNED ON. UNIT IS OVER TWO YEARS OLD AND HISTORY HAS ALSO SHOWN THAT EVENTS WITH THIS DEVICE HAVE BEEN A RESULT OF DROPPING DEVICE, MECHANICAL WEAR AND OR BLOCKING VENTS DURING USE. DEVICE IS THERMALLY PROTECTED. MDR FILED SOLELY ON COMPLAINT THAT DEVICE OVERHEATED WHEN TURNED ON. MALFUNCTION NOT CONFIRMED. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Additional Manufacturer Narrative · 1

    DEVICE ALLEGEDLY OVERHEATED WHEN TURNED ON. UNIT IS OVER TWO YEARS OLD AND HISTORY HAS ALSO SHOWN THAT EVENTS WITH THIS DEVICE HAVE BEEN A RESULT OF DROPPING DEVICE, MECHANICAL WEAR AND OR BLOCKING VENTS DURING USE. DEVICE IS THERMALLY PROTECTED. MDR FILES SOLELY ON COMPLAINT THAT DEVICE OVERHEATED WHEN TURNED ON. MALFUNCTION NOT CONFIRMED. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Description of Event or Problem · 1

    THE UNIT ALLEGEDLY OVERHEATED WHEN IT WAS TURNED ON. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE UNIT ALLEGEDLY OVERHEATED WHEN IT WAS TURNED ON. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEBULIZERS TO DELIVER AEROSOLS 868.5630 CAF MEDEL S.P.A. IRC1710

    Patients

    Seq Age Sex Outcome Treatment
    1