BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3851791 · Received April 11, 2014

    Report

    Report Number
    8020893-2014-00865
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 26, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS CURRENTLY BEING INVESTIGATED, AS ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM (B)(6) STATED AN 840 VENTILATOR EXPERIENCED A DEVICE ALERT WHICH RENDERED THE GRAPHICAL USER INTERFACE (GUI) DISPLAY INOPERABLE. PATIENT INVOLVEMENT IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221177 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1