BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTLAB HME FILTER

    MDR report key: 2493997 · Received March 14, 2012

    Report

    Report Number
    2246980-2012-00001
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Date of Event
    February 1, 2012
    Report Date
    March 14, 2012
    Manufacturer
    VENTLAB CORP.
    Product Code
    CAH
    PMA / PMN Number
    K030271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE DESCRIBED IN SECTION 5 WAS NOT RETURNED FOR OUR INVESTIGATION. THE USER FACILITY RETURNED UNUSED SAMPLES FROM THE SAME LOT. THESE SAMPLES WERE EVALUATED AND RESULTS FOUND NO BLOCKAGE AND NO EVIDENCE OF FLASHING. WITHOUT THE ACTUAL SAMPLE, IT IS INCONCLUSIVE AS TO WHAT THE BLOCKAGE WAS AND HOW IT OCCURRED.

    Description of Event or Problem · 1

    HME WAS ON A PT THAT WAS ON A VENTILATOR. PT WAS UNABLE TO BREATH DUE TO THE PLASTIC OBSTRUCTION INSIDE THE HME. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTLAB HME FILTER HME FILTER CAH VENTLAB CORP. 12424

    Patients

    Seq Age Sex Outcome Treatment
    1