BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2925315 · Received January 17, 2013

    Report

    Report Number
    8020893-2013-00115
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 20, 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
    WY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE ON A PT AN 840 VENTILATOR WAS DISPLAYING A LOW O2 ERROR MESSAGE. THE PT WAS REMOVED FROM THE VENTILATOR AND PLACED ON A SECOND VENTILATOR. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE CUSTOMER REPORTED TO HAVE REPLACED THE O2 CELL AND THAT RESOLVED THE ISSUE. THE UNIT PASSED EXTENDED SELF-TESTING. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26661 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT 840

    Patients

    Seq Age Sex Outcome Treatment
    1