BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3760817 · Received April 9, 2014

    Report

    Report Number
    8020893-2014-00842
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 9, 2014
    Report Date
    March 10, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB) AND THE BACKLIGHT ASSEMBLY. THE DEVICE PASSED ALL TESTS ACCORDING TO MANUFACTURER SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM (B)(6) STATED AN 840 VENTILATOR EXPERIENCED CONTINUOUS ALARM WHILE BEING USED ON A PT. THE PT WAS REMOVED FROM THE VENTILATOR AND PLACED ON ANOTHER VENTILATOR. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212977 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention