BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2191947 · Received July 22, 2011

    Report

    Report Number
    8020893-2011-00302
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SERVICE REPORT SHOWS THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING WHILE IN USE ON A PT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. PURITAN BENNETT WAS NOT AUTHORIZED TO REPAIR THE UNIT. IT IS NOT VERIFIED THAT THE VENT WAS INOPERABLE, AND THAT A MALFUNCTION OCCURRED. THE CUSTOMER REPORTED TO HAVE REPLACED THE GUI PCB. THE PURITAN BENNETT CUSTOMER SUPPORT ENGINEER (CSE) UPDATED THE SOFTWARE AND CONDUCTED FINAL TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1