BEUDAMED
    FDA Adverse Event Death Summary report: N

    760 VENTILATOR

    MDR report key: 385297 · Received March 29, 2002

    Report

    Report Number
    8020893-2002-00001
    Event Type
    Death
    Date Received
    March 29, 2002
    Date of Event
    January 5, 2002
    Report Date
    March 29, 2002
    Manufacturer
    NELLCOR PURITAN BENNETT IRE.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A TYCO HEALTHCARE EMPLOYEE RECEIVED INFORMATION REPORTING THAT A PATIENT WAS USING A PASSY-MUIR VALVE AND THE 760 VENTILATOR WAS SET-UP IN SPEAKING VALVE MODE. IT IS REPORTED THAT THE PATIENT TUBING BECAME SPEAKING VALVE MODE. IT WAS REPORTED THAT THE PATIENT TUBING BECAME DISCONNECTED AT THE TRACH TUBE AND THE VENTILATOR CONTINUED TO CYCLE AT THE ENTERED SETTINGS BUT NO ALARM WAS ENUNCIATED. AT THE TIME OF THE EVENT, THERE WAS NO ONE IN THE PATIENT ROOM. THE 700 VENTILATOR SYSTEM OFFERS A SPEAKING VALVE OPTION, FOR WHICH THE OPERATIONS MANUAL WARNS THAT WHEN USING THAT OPTION CERTAIN ALARMS ARE DISCONNECTED AND THE VENTILATOR'S ABILITY TO DETECT SOME CONDITIONS IS DECREASED. THE OPERATOR IS WARNED TO ENSURE THAT ALL VENTILATOR SETTINGS AND ALARM LIMITS ARE SET APPROPRIATELY. THE FIRM HAS DISCUSSED USE OF THE DEVICE WITH THE CUSTOMER INCLUDING SETTING AND MONITORING OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 760 VENTILATOR VOLUME MECHANICAL VENTILATOR CBK NELLCOR PURITAN BENNETT IRE. 760 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death