BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3872327 · Received April 18, 2014

    Report

    Report Number
    8020893-2014-00949
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE AND VERIFIED THE CUSTOMER REPORTED ISSUE. THE CSE REPLACED THE CUSTOMER SUPPLIED GRAPHIC USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU), WHICH RESOLVED THE CUSTOMER REPORTED ISSUE. COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE (B)(6) REPORTING THE DEVICE HAD "NO DISPLAY". THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238489 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1