BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3962467 · Received July 11, 2014

    Report

    Report Number
    8020893-2014-01658
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) TOUCH FRAME PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A CUSTOMER IN THE USA STATING THAT AN 840 VENTILATOR HAD AN UNRESPONSIVE TOUCH SCREEN WHILE IN USE ON A PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON A SECOND VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407592 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention