BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3772025 · Received December 30, 2013

    Report

    Report Number
    8020893-2013-03277
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    December 2, 2013
    Manufacturer
    DIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD A GARBLED DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED. COVIDIEN TECH SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. THE CUSTOMER WAS ADVISED TO SWAP DISPLAYS TO IDENTIFY AND REPLACE THE FAILED PART. THE CUSTOMER REPORTED TO HAVE IDENTIFIED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AS THE CAUSE OF THE MALFUNCTION AND WILL CALL BACK WITH AUTHORIZATION FOR A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) TO REPAIR THE DEVICE. AT THIS TIME THE UNIT HAS NOT BEEN REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680968 840 VENTILATOR VENTILATOR CBK DIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1