BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4101873 · Received August 25, 2014

    Report

    Report Number
    8020893-2014-02101
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    June 16, 2014
    Report Date
    August 6, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) TO BREATH DELIVERY (BD) CABLE AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COVIDIEN FIELD SERVICE ENGINEER (FSE) RECEIVED A GRAPHIC USER INTERFACE (GUI)TO BREATH DELIVERY (BD) CABLE, WHICH WAS REPORTED TO BE MALFUNCTIONING. VISUAL INSPECTION REVEALED SLIGHT ABRASIONS ON THE OUTER INSULATION OF THE CABLE WHERE IT WAS ATTACHED TO THE CART. FUNCTIONAL TESTS WERE PERFORMED, AND REPORTED ISSUE COULD NOT BE DUPLICATED. THE UNIT POWERED UP NORMALLY, AND NO ERRORS WERE RECORDED IN THE DIAGNOSTIC LOGS. THE CABLE WAS MANIPULATED IN ALL DIRECTIONS WHILE IN VENT MODE IN AN ATTEMPT TO INDUCE A FAULT BUT NO FAULT OCCURRED. A REVIEW OF THE VENTILATOR DIAGNOSTIC LOGS REVEALED THAT NO ERRORS AND NO ALARMS WERE OBSERVED DURING THE 24 HOURS THE UNIT SUCCESSFULLY RAN IN VENTILATION MODE. HOWEVER, THE GUI TO BD CABLE WAS REPLACED AS A PRECAUTIONARY MEASURE.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO STATING THAT THE 840 VENTILATOR EXPERIENCED A LOSS OF COMMUNICATION. THE VENTILATOR WAS NOT IN USE ON A PT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511346 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1