BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3801683 · Received April 25, 2014

    Report

    Report Number
    8020893-2014-00999
    Event Type
    Injury
    Date Received
    April 25, 2014
    Report Date
    March 28, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) COULD NOT DUPLICATE THE CUSTOMER REPORTED MALFUNCTION OF DEVICE'S INCORRECT DATE/TIME. THE DEVICE PASSED ALL TESTS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN 840 VENTILATOR HAD THE WRONG TIME AND DATE DISPLAYED. THE DEVICE WAS BEING USED ON A PT WHEN EVENT OCCURRED. THE PT WAS REMOVED FROM THE DEVICE AND PLACED ON AN ALTERNATE VENTILATOR. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT. THE DATE OF THE EVENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250341 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention