BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2925316 · Received January 17, 2013

    Report

    Report Number
    8020893-2013-00114
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 20, 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 DURING USE ON A PT THE DISPLAY WAS FREEZING UP ON AN 840 VENTILATOR. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE CUSTOMER INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED MALFUNCTION. COVIDIEN WAS NOT AUTHORIZED TO REPAIR THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26227 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT 840

    Patients

    Seq Age Sex Outcome Treatment
    1