BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3853595 · Received April 3, 2014

    Report

    Report Number
    8020893-2014-00776
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    March 5, 2014
    Manufacturer
    NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CSE REPLACED THE TOUCHFRAME. THE DEVICE PASSED ALL TESTS ACCORDING TO MFG SPECS. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED AN UNRESPONSIVE GRAPHICAL USER INTERFACE (GUI). THERE WAS NO PT INVOLVEMENT AT THE TIME OF THE EVENT. THE DATE OF THE EVENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201770 840 VENTILATOR CBK NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1