BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 2031914 · Received March 22, 2011

    Report

    Report Number
    1525712-2011-00133
    Event Type
    Other
    Date Received
    March 22, 2011
    Date of Event
    February 26, 2011
    Report Date
    March 22, 2011
    Manufacturer
    EMG
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY REPORTED. INFO WAS RECEIVED STATING THE SWITCH SPARKED AND THE DEVICE NO LONGER FUNCTIONS. DEVICE HAS BEEN IN SERVICE FOR 20 MONTHS. DEVICE IS PORTABLE AND ITS UNK IF THE DEVICE WAS DROPPED PRIOR TO USE. FILING IS SOLELY ON THE USER'S ALLEGATION THAT DEVICE SPARKED. MALFUNCTION IS NOT CONFIRMED. MFR IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Description of Event or Problem · 1

    THE TBM RECEIVED AN EMAIL FROM THE DEALER ALLEGING THE NEBULIZER IS NOT WORKING AT ALL AND SPARKED AT THE ON/OFF SWITCH. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE CAF EMG IRC1740

    Patients

    Seq Age Sex Outcome Treatment
    1