BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3772029 · Received December 31, 2013

    Report

    Report Number
    8020893-2013-03279
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    December 6, 2013
    Report Date
    December 6, 2013
    Manufacturer
    COVIDIEN, FORMELRY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR WAS INOPERABLE. THE FAILURE HAPPENED WHEN THE DEVICE WAS NOT USED ON A PT. COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. TSE RECOMMENDED REPLACING THE GRAPHIC USER INTERFACE (GUI) TO BREATH DELIVERY (BD) CABLE ASSEMBLY. COVIDIEN WAS NOT AUTHORIZED TO EVALUATE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683116 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMELRY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1