BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3851817 · Received April 11, 2014

    Report

    Report Number
    8020893-2014-00877
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Report Date
    March 14, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) REPLACED THE GRAPHICAL USER INTERFACE (GUI) TOUCHFRAME. THE UNIT PASSED THE PERFORMANCE VERIFICATION TEST (PVT) PER THE MANUFACTURER'S SPECIFICATIONS AT THE TIME OF SERVICE. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS REC'D FROM THE USA WITH INFO STATING THAT AN 840 VENTILATOR HAD A COMMUNICATIONS ISSUE AND THAT THE TOUCHFRAME WAS INTERMITTENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE DATE OF THE EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221239 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1