BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 4260239 · Received November 18, 2014

    Report

    Report Number
    8020893-2014-02471
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 20, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB). THE CSE UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE UNIT THEN PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.(B)(4)

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT AN ALERT WAS GENERATED FROM AN 840 VENTILATOR WHILE IN USE ON A PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON A SECOND VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746271 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention