BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2781935 · Received October 5, 2012

    Report

    Report Number
    8020893-2012-00884
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    August 3, 2012
    Report Date
    September 5, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE 840 VENTILATOR WAS INOPERATIVE WHILE IN USE ON A PT. THERE WAS NO PT HARMED OR INJURED AS A RESULT OF THE VENT. COVIDIEN WAS NOT ABLE TO DUPLICATE THE ALLEGED MALFUNCTION. THE KEYBOARD ASSEMBLY WAS REPLACED AS PRECAUTIONARY. THE VENTILATOR PASSED ALL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1