BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3971162 · Received April 29, 2014

    Report

    Report Number
    8020893-2014-01017
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Report Date
    April 1, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE GRAPHIC USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB) AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA WITH INFORMATION STATING THAT WHEN AN 840 VENTILATOR WAS POWERED ON THE SCREEN WAS BLANK. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED. THE DATE OF THE EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256480 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1