BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HUMID-VENT FILTER COMPACT STR STERIL

    MDR report key: 3813218 · Received March 31, 2014

    Report

    Report Number
    8040412-2014-00080
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 21, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES WHILE A PATIENT WAS ON AN INVASIVE ARTIFICIAL RESPIRATION; A NEBULIZER TREATMENT WAS ADMINISTERED. THE NEBULIZER TREATMENT HAPPENED BETWEEN THE CATHETER MOUNT TUBE AND HME FILTER. OVER THE COURSE OF THE DAY THE RESPIRATORY VOLUME OF THE PATIENT DECREASED. THE PATIENT BECAME STRESSED AND SHOWED SIGNS OF RAPID BREATHING. INTERVENTION - THE SITUATION IMPROVED WHEN THE FILTER WAS CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189893 HUDSON HUMID-VENT FILTER COMPACT STR STERIL H-V FILTER CAH TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention