BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3962758 · Received June 23, 2014

    Report

    Report Number
    8020893-2014-01519
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 30, 2014
    Manufacturer
    COVIDIEN, FORMELRY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE TELEPHONE, AND RECOMMENDED REPLACING THE EXPIRATORY FLOW SENSOR. THE REPAIR IS ONGOING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PT USE, AN 840 VENTILATOR GENERATED AN ALERT ERROR CODE INDICATING "EXPIRATORY PRESSURE STUCK". THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364586 840 VENTILATOR CBK COVIDIEN, FORMELRY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1