BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTER-STERILE

    MDR report key: 1812419 · Received August 12, 2010

    Report

    Report Number
    1417411-2010-00027
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    June 7, 2010
    Report Date
    July 28, 2010
    Manufacturer
    TELEFELX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER FOR EVAL, THEREFORE, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: IT WAS FOUND THAT AIR FLOW WAS LOST WHILE IN USE. ALSO THE CONNECTION TO THE FLOWMETER WAS UNSTABLE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEBULIZER ADAPTER-STERILE NEBULIZER ADAPTOR CAF TELEFELX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1