BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 4113299 · Received September 15, 2014

    Report

    Report Number
    8020893-2014-02210
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    July 28, 2014
    Report Date
    September 15, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION AND REPLACED THE KEYBOARD. THE VENTILATOR PASSED ALL TESTS AND WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT THE SCREEN ON AN 840 VENTILATOR WAS BLOCKED. THE VENTILATOR WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED MALFUNCTION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO PATIENT HARM OR INJURY AS A RESULT OF THE TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570434 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention