BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3243213 · Received July 18, 2013

    Report

    Report Number
    8020893-2013-01632
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 19, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 STOPPED CYCLING. NO PT INVOLVEMENT. COVIDIEN TECH SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH CUSTOMER OVER THE PHONE AND SUGGESTED LOOKING AT THE LEDS ON THE GRAPHIC USER INTERFACE (GUI) AND BREATH DELIVERY UNIT (BDU) CPU BOARDS FOR ERROR CODES. THE CUSTOMER REPORTED TO HAVE FOLLOWED THE TSE RECOMMENDATIONS AND REPORTED HE WILL REPLACE THE POWER SUPPLY AND POSSIBLY THE BDU CPU. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335428 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1