BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3201962 · Received June 27, 2013

    Report

    Report Number
    8020893-2013-01401
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 8, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN 840 VENTILATOR HAD AN ERRATIC DISPLAY. NO PT INVOLVEMENT. COVIDIEN TECH SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH CUSTOMER OVER THE PHONE AND SUGGESTED REPLACING THE GUI CPU PCB TO ISOLATE THE PROBLEM. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291812 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1