BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3922492 · Received June 2, 2014

    Report

    Report Number
    8020893-2014-01336
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 8, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE, AND VERIFIED THE GRAPHIC USER INTERFACE (GUI) ERROR CODES INDICATING A LOSS OF COMMUNICATION. THE CSE REPLACED THE GUI CABLE, AND UPDATED THE SOFTWARE. ALL REQUIRED CALIBRATIONS AND TESTS WERE PERFORMED, AND THE UNIT WAS OPERATING WITHIN MANUFACTURER'S SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT AN 840 VENTILATOR GRAPHIC USER INTERFACE (GUI) WAS DISPLAYING ERROR CODES, AND THE UNIT WAS INOPERABLE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321817 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1