BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALL FILTER

    MDR report key: 1790346 · Received July 30, 2010

    Report

    Report Number
    1790346
    Event Type
    Death
    Date Received
    July 30, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 30, 2010
    Manufacturer
    PALL MANUFACTURING
    Product Code
    CAH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VENT ALARMING, PT UP IN CHAIR, TRACH PULLED OUT, PT'S FACE AND NECK ON LEFT SIDE BEGINNING TO SWELL INDICATING SUBCUTANEOUS EMPHYSEMA. RAPID RESPONSE CALLED, RT REMOVED TRACH AND BAG MASK, NEW TRACH PLACED. CPR INITIATED BY (B)(6) NURSE PERFORMED APPROX 30 SECS, WHEN DEFIB PADS APPLIED, CPR STOPPED, SHOWED SINUS TECH ON MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL FILTER VENT FILTER CAH PALL MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| R