BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3210174 · Received July 3, 2013

    Report

    Report Number
    8020893-2013-01506
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 5, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE SERVICE REPORT SHOWS THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER REPORTED TO HAVE REPLACED THE BREATH DELIVERY UNIT (BDU) CPU PCB. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) WAS ONLY AUTHORIZED TO UPLOAD THE SOFTWARE. THE VENTILATOR PASSED ALL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305445 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1