BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3940143 · Received March 21, 2014

    Report

    Report Number
    8020893-2014-00666
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 19, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED MALFUNCTION. THE CSE REPLACED THE KEYBOARD ASSEMBLY. THE DEVICE PASSED THE EXTENDED SELF-TEST (EST), SHORT SELF-TEST (SST) AND THE ELECTRICAL SAFETY TEST; THE DEVICE WAS FOUND TO OPERATE WITHIN MFG SPECS. IN THE EVENT THAT ADD'L INFO IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED THAT AN 840 VENTILATOR HAD AN UNRESPONSIVE KEYBOARD WHILE BEING USED ON A PT. IT WAS REPORTED THAT THE SCREEN LOCK KEY ON THE KEYBOARD IS ACTIVATING WITHOUT BEING PRESSED. THERE WAS NO REPORT OF PT INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168445 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention