BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 4231435 · Received November 6, 2014

    Report

    Report Number
    8020893-2014-02448
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 23, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE, AND VERIFIED THE REPORTED MALFUNCTION. THE CSE REPLACED THE REPLACED THE ANALOG INTERFACE (AI) PRINTED CIRCUIT BOARD (PCB), AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE (B)(6) THAT, DURING PATIENT USE, THE 840 VENTILATOR SHUT DOWN. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714012 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention