BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 4771788 · Received May 14, 2015

    Report

    Report Number
    8020893-2015-00432
    Event Type
    Injury
    Date Received
    May 14, 2015
    Report Date
    April 22, 2015
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THE REPORTED MALFUNCTION WITH THE CUSTOMER OVER THE TELEPHONE. THE TSE RECOMMENDED REPLACING THE GRAPHIC USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU). THE CUSTOMER CALLED FOR AN ON-SITE SERVICE. THE COVIDIEN CUSTOMER SERVICE ENGINEER (CSE) REPLACED THE GUI CPU AND INSTALLED THE LATEST SOFTWARE REVISION, TO RESOLVE THE ISSUE. THE VENTILATOR PASSED ALL TESTS, CALIBRATIONS, AND IT WAS OPERATING WITHIN THE MANUFACTURING SPECIFICATIONS. THE VENTILATOR IS BACK IN SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING PATIENT USE, THE VENTILATOR GRAPHIC USER INTERFACE (GUI) WENT BLANK. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR WITHOUT ANY REPORTED HARM. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315212 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention