BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3853837 · Received April 18, 2014

    Report

    Report Number
    8020893-2014-00952
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Report Date
    March 21, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THE ISSUE WITH THE CUSTOMER OVER THE PHONE. THE TSE SUGGESTED REPLACING THE LIQUID CRYSTAL DISPLAY (LCD) PANEL. COVIDIEN WAS NOT AUTHORIZED TO SERVICE DEVICE. COVIDIEN REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN 840 VENTILATOR HAD AN ERRATIC GRAPHIC USER INTERFACE (GUI) DISPLAY. DEVICE WAS NOT BEING USED ON A PATIENT WHEN EVENT OCCURRED. THE DATE OF THE EVENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238911 840 VENTILATOR CBK: VENTILATOR, CONTINUOUS FACILITY CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1