BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3943549 · Received April 30, 2014

    Report

    Report Number
    8020893-2014-01021
    Event Type
    Malfunction
    Date Received
    April 30, 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
    MA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CSE INSPECTED THE DEVICE AND FOUND ERROR CODES IN THE MEMORY LOG RELEVANT TO 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. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED AN INTERMITTENT COMMUNICATION ERROR WHICH RENDERED THE DEVICE INOPERABLE. THERE WAS NO PATIENT INVOLVEMENT. THE DATE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258702 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1