BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2850460 · Received November 26, 2012

    Report

    Report Number
    8020893-2012-01271
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD A BLANK GUI DISPLAY WHILE IN USE ON A PT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE CUSTOMER REPORTED TO HAVE REPLACED THE GRAPHICAL USER INTERFACE (GUI) CPU PCB. COVIDIEN WAS NOT AUTHORIZED TO REPAIR THE VENT. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) WAS ONLY AUTHORIZED TO UPLOAD THE SOFTWARE. THE VENTILATOR PASSED ALL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT 840

    Patients

    Seq Age Sex Outcome Treatment
    1