BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840

    MDR report key: 1070209 · Received June 27, 2008

    Report

    Report Number
    1070209
    Event Type
    Malfunction
    Date Received
    June 27, 2008
    Date of Event
    June 19, 2008
    Report Date
    June 27, 2008
    Manufacturer
    PURITAN BENNETT CORPORATION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    THE NURSE WAS CARING FOR THE PATIENT AT THE BEDSIDE AND TURNED THE PATIENT ON HIS SIDE. THE VENTILATOR BEGAN ALARMING FOR A CIRCUIT DISCONNECT. THE NURSE WAS UNABLE TO CLEAR THE ALARM AND CALLED RESPIRATORY THERAPY. RT CHECKED THE CIRCUIT AND PRESSED THE RESET BUTTON ON GUI (GRAPHICAL USER INTERFACE) KEYBOARD. THE ALARM WOULD NOT GO AWAY. RT CYCLED POWER TO THE VENTILATOR, AND IT CAME UP AGAIN WITH AN ERROR MESSAGE. A SECOND VENTILATOR OF THE SAME MODEL WAS IMMEDIATELY BROUGHT IN AS A REPLACEMENT. THE MANUFACTURER'S FIELD SERVICE ENGINEER WAS NOTIFIED OF THE EVENT AND WILL COME ON SITE TO COMPLETE THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR CBK PURITAN BENNETT CORPORATION 840 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *