BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4193535 · Received October 22, 2014

    Report

    Report Number
    8020893-2014-02385
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 3, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE AND REPLACED THE KEYBOARD. THE VENTILATOR PASSED EXTENDED SELF TESTING (EST), SHORT SELF TESTS (SST), AND ELECTRICAL SAFETY.(B)(4)

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION THAT, DURING PATIENT USE, AN ERROR CODE OCCURRED INDICATING AN UNRESPONSIVE GRAPHIC USER INTERFACE (GUI) KEY. THERE WAS NO NEGATIVE MEDICAL IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673947 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1