BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2913506 · Received January 9, 2013

    Report

    Report Number
    8020893-2013-00064
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    CONVIDIEN, FORMERLY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD A BLANK DISPLAY. NO PATIENT INVOLVEMENT. COVIDIEN TECH SUPPORT ENGINEER (TSE) TROUBLESHOOTS THIS ISSUE WITH CUSTOMER OVER THE PHONE AND SUGGESTED TO REPLACE THE GRAPHIC USER INTERFACE (GUI) CPU PCB. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12120 840 VENTILATOR VENTILATOR CBK CONVIDIEN, FORMERLY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1