BEUDAMED
    FDA Adverse Event Death Summary report: N

    PASSY - MUIR VALVE 2001

    MDR report key: 1061865 · Received June 18, 2008

    Report

    Report Number
    MW5007336
    Event Type
    Death
    Date Received
    June 18, 2008
    Date of Event
    May 31, 2008
    Report Date
    June 9, 2008
    Manufacturer
    PASSY - MUIR, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    QUADRIPLEGIC PATIENT WITH TRACH, WEAK RESPIRATORY STATUS -- IE. ONLY DIAPHRAGMATIC BREATHING. PASSY MUIR SPEAKING VALVE WAS PLACED BY STAFF MEMBER WHO THEN LEFT THE ROOM. THIRTY MINS LATER, PATIENT WAS FOUND EXPIRED. IT WAS DISCOVERED THAT TRACH CUFF WAS INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSY - MUIR VALVE 2001 SPEAKING VALVE BTO PASSY - MUIR, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Death SHILEY #6 CUFFED| TUBE.