BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR SYSTEM

    MDR report key: 746289 · Received October 3, 2005

    Report

    Report Number
    MW1036823
    Event Type
    Injury
    Date Received
    October 3, 2005
    Date of Event
    September 21, 2005
    Report Date
    October 3, 2005
    Manufacturer
    TYCO HEALTHCARE PURITAN BENNETT
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A PT WAS CONNECTED TO A PURITAN BENNETT 840 VENTILATOR SYSTEM. THE VENTILATOR HAD A CRITICAL FAILURE AT ROUGHLY 0100 HRS ON 9/21/2005. THE VENTILATOR ALARMED AND PRESENTED WITH AN ERROR MESSAGE THAT READ "MONITOR BREATH TIME FAILS." THE PT SURVIVED AND WAS NOT ADVERSELY AFFECTED. THE MFR -PURITAN BENNETT- WAS NOTIFIED OF THE FAILURE ON 9/23/2005. A SERVICE TECH WAS SENT ON SITE. THE ERROR LOGS WERE REVIEWED AND IT WAS DETERMINED THAT THE MODE OF FAILURE WAS A BAD CPU BOARD. THE VENTILATOR IS AWAITING BOARD REPLACEMENT AND WILL THEN BE RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR SYSTEM VENTILATOR CBK TYCO HEALTHCARE PURITAN BENNETT 840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R