BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALL CONSERVE 100 BREATHING CIRCUIT FILTER

    MDR report key: 1820413 · Received August 30, 2010

    Report

    Report Number
    2647898-2010-00005
    Event Type
    Death
    Date Received
    August 30, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 30, 2010
    Manufacturer
    PALL LIFE SCIENCES PUERTO RICO, LLC
    Product Code
    CAH
    PMA / PMN Number
    K791307
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TENSION PNEUMOTHORAX CAUSING CARDIOPULMONARY ARREST. FILTER MAY HAVE BEEN DEFECTIVE. AS IT WAS VERY DIFFICULT TO BAG AND VENTILATE PATIENT DURING CODE. ONCE FILTER WAS REMOVED, NO MORE RESISTANCE WAS MET AND PATIENT WAS OXGENATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL CONSERVE 100 BREATHING CIRCUIT FILTER BREATHING CIRCUIT FILTER CAH PALL LIFE SCIENCES PUERTO RICO, LLC BB100F UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death