BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3980994 · Received July 24, 2014

    Report

    Report Number
    8020893-2014-01801
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 7, 2014
    Manufacturer
    COVIDIEN GALWAY
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED A SAFETY VALVE OPEN CONDITION WHICH RENDERED THE VENTILATOR INOPERABLE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435123 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN GALWAY 840

    Patients

    Seq Age Sex Outcome Treatment
    1