BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3772205 · Received January 2, 2014

    Report

    Report Number
    8020893-2014-00009
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Report Date
    December 3, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN 840 VENTILATOR WAS INOPERABLE. IT IS UNK AT THIS TIME IF THE MALFUNCTION OCCURRED DURING PT USE. THE EVALUATION AND REPAIR OF THE DEVICE IS STILL IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1