BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4071910 · Received August 4, 2014

    Report

    Report Number
    8020893-2014-01985
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 16, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE AND REPLACED THE GRAPHIC USER INTERFACE (GUI) TOUCHFRAME, WHICH RESOLVED THE REPORTED ISSUE. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO STATING THAT AN 840 VENTILATOR HAD AN ERROR CODE. A REVIEW OF THE ERROR CODES INDICATE A TOUCH SCREEN BLOCKED. THE MALFUNCTION DID NOT OCCUR DURING PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455423 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1