BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3853571 · Received April 3, 2014

    Report

    Report Number
    8020893-2014-00780
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    October 13, 2014
    Report Date
    March 5, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. THE TSE RECOMMENDED A SOFTWARE UPDATE AND TO REPORT ANY PROBLEMS WITH VENT. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    A REPORT FROM THE USA WAS RECEIVED WITH INFO STATING THAT AN 840 VENTILATOR STOPPED CYCLING. THE VENTILATOR WAS NOT IN USE ON A PT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201765 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1