BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 4101575 · Received August 25, 2014

    Report

    Report Number
    8020893-2014-02093
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN CUSTOMER REPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CSE REPLACED THE BREATH DELIVERY (BD) TO GRAPHICAL USER INTERFACE (GUI) CABLE TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL CALIBRATIONS, SHORT SELF-TEST (SST), EXTENDED SELF-TEST (EST) AND PERFORMANCE VERIFICATION TESTING ACCORDING TO MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 1

    A REPORT REC'D FROM THE BIOMEDICAL DEPARTMENT OF THE USER FACILITY STATED AN 840 VENTILATOR EXPERIENCED AN ERROR WHICH RENDERED THE VENTILATOR INOPERABLE. DURING A F/U WITH THE BIOMEDICAL ENGINEER, THE DEVICE WAS FOUND TO HAVE STOPPED CYCLING WHILE A RESPIRATORY THERAPIST (RT) WAS IN THE PATIENT'S ROOM. THE PATIENT WAS REMOVED FROM THE DEVICE AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513946 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention