BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 4252174 · Received November 14, 2014

    Report

    Report Number
    8020893-2014-02478
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE TELEPHONE. THE TSE RECOMMENDED PERFORMING THE GROUND ISOLATION CHECK; RESEAT THE GRAPHICAL USER INTERFACE (GUI) CABLE; RUN THE EXTENDED SELF-TESTING (EST), AND CONTINUOUSLY RUN THE VENTILATOR FOR 48 HOURS. THE CUSTOMER REPORTED TO HAVE FOLLOWED THE TSE RECOMMENDATIONS, AND THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. THE DEVICE HAS BEEN RETURNED TO SERVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PATIENT USE, THE 840 VENTILATOR GRAPHICAL USER INTERFACE (GUI) HAD A BLANK DISPLAY. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737152 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention