BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTLAB HME FILTER

    MDR report key: 2541789 · Received April 11, 2012

    Report

    Report Number
    2246980-2012-00002
    Event Type
    Malfunction
    Date Received
    April 11, 2012
    Date of Event
    March 4, 2012
    Report Date
    March 28, 2012
    Manufacturer
    VENTLAB CORP.
    Product Code
    CAH
    PMA / PMN Number
    K030271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON VISUAL EXAMINATION OF THE RETURNED SAMPLE, IT WAS DETERMINED THAT FLASHING COMPLETELY OCCLUDED THE INTERNAL DIAMETER OF THE PT PORT OF THE FILTER.

    Description of Event or Problem · 1

    HME WAS PLACED ON A VENTILATOR CIRCUIT; VENTILATOR STARTED ALARMING IMMEDIATELY WHEN CONNECTED TO PT. THERAPIST REMOVED PT FROM VENTILATOR AND STARTED BAGGING PT. ONE SIDE OF THE HME WAS COMPLETELY BLOCKED, WHICH COULD ONLY BE SEEN BY LOOKING UP INSIDE THE HME. AIR COULD NOT PASS THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTLAB HME FILTER HME FILTER CAH VENTLAB CORP. 12606

    Patients

    Seq Age Sex Outcome Treatment
    1