BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTILATOR CIRCUIT

    MDR report key: 1059373 · Received June 10, 2008

    Report

    Report Number
    1059373
    Event Type
    Death
    Date Received
    June 10, 2008
    Date of Event
    May 3, 2008
    Report Date
    June 9, 2008
    Manufacturer
    FISHER PAYKEL
    Product Code
    BZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A FEMALE WITH CHRONIC RESPIRATORY FAILURE AND VENTILATOR DEPENDENCY WAS ADMITTED WITH SEIZURES FROM NURSING HOME IN '08. AT APPROXIMATELY SIX WEEKS LATER, THE PT WAS DISCOVERED UNRESPONSIVE WITH THE VENTRICULAR CIRCUIT TUBING DISCONNECTED. SHE WAS RESUSCITATED BUT REMAINED IN A PERSISTENT VEGETATIVE STATE AND EXPIRED AT ABOUT ONE MONTH LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR CIRCUIT S/A BZO FISHER PAYKEL RT210 080229

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PURITAN BENNETT VENTILATOR MODEL PB840