BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HUMID VENT FILTER, SMALL

    MDR report key: 3063708 · Received April 12, 2013

    Report

    Report Number
    8040412-2013-00069
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING RETAINED BY THE HOSPITAL RISK MANAGEMENT GROUP. IT IS UNCERTAIN, AT THIS TIME, WHETHER THE SAMPLE WILL BE AVAILABLE FOR INVESTIGATION PURPOSES.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING A SURGICAL PROCEDURE (BACK SURGERY WITH PATIENT IN PRONE POSITION) THE FILTER STOPPED WORKING AND THE PATIENT'S STATS BEGAN TO DROP. THE SURGEON DECLARED THE PATIENT UNSTABLE AND BEGAN CLOSURE TO THE SURGICAL SITE AS THE ANESTHESIA STAFF WAS TRYING TO DETERMINE WHAT WAS HAPPENING. THE ANESTHESIA STAFF DISCOVERED THE HME FILTER HAD CLOGGED UP, WHICH WAS RESTRICTING VENTILATION FLOW. THE FILTER WAS CHANGED OUT AND THE PATIENT WAS STABILIZED AND THE SURGEON DECIDED TO CONTINUE WITH THE BACK PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157513 HUDSON HUMID VENT FILTER, SMALL HUMID-VENT FILTER CAH TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention