BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3243214 · Received July 18, 2013

    Report

    Report Number
    8020893-2013-01629
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 19, 2013
    Manufacturer
    COVIDIEN, FORMERL NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN 840 VENTILATOR HAD AN ERRATIC SCREEN. NO PT INVOLVEMENT REPORTED. COVIDIEN WAS NOT AUTHORIZED TO REPAIR THE UNIT. THE CUSTOMER REPORTED TO HAVE REPLACED THE GRAPHIC USER INTERFACE (GUI) CPU PCB. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) UPDATED THE SOFTWARE AND CONDUCTED FINAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336439 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERL NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1