BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3934267 · Received June 27, 2014

    Report

    Report Number
    8020893-2014-01513
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 30, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THE MALFUNCTION WITH THE CUSTOMER OVER THE TELEPHONE. THE TSE RECOMMENDED RUNNING THE VENTILATOR ON TEST LUNG. THE CUSTOMER REPORTED TO HAVE RUN THE UNIT OVERNIGHT ON A TEST LUNG AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE UNIT PASSED ALL TESTS AND CALIBRATIONS AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT DURING PATIENT USE, AN 840 VENTILATOR GENERATED A SEVERE OCCLUSION ALARM RESULTING IN THE PATIENT BEING REMOVED FROM THE UNIT AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377948 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention