BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4221676 · Received November 3, 2014

    Report

    Report Number
    8020893-2014-02439
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND WAS NOT ABLE TO DUPLICATE THE ALLEGED MALFUNCTION. THE CSE REPLACED THE POWER CORD AS A PRECAUTION AND PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.(B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT WHEN THE POWER CORD ON AN 840 VENTILATOR WAS BEING UNPLUGGED FROM THE AC (ALTERNATE CURRENT) WALL SOCKET, THERE WAS A SPARK. THE VENTILATOR WAS NOT POWERED ON, AND IT WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702917 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1