BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTOR

    MDR report key: 1881405 · Received October 7, 2010

    Report

    Report Number
    1417411-2010-00036
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 8, 2010
    Report Date
    September 17, 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

    THE RESULTS OF THE DEVICE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE USER COULD NOT BRING THE OXYGEN FLOW TO MORE THAN 10 L/MIN WHEN THE ADAPTOR WAS SET. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEBULIZER ADAPTOR NEBULIZER ADAPTOR CAF TELEFELX MEDICAL NA K11928

    Patients

    Seq Age Sex Outcome Treatment
    1