BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2971155 · Received February 1, 2013

    Report

    Report Number
    8020893-2013-00261
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DUE TO A VENTILATOR MALFUNCTION THE PT WAS PLACED ON A SECOND VENTILATOR. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE COMPRESSOR PCB. THE UNIT PASSED EXTENDED SELF-TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45280 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1