BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2241154 · Received August 17, 2011

    Report

    Report Number
    8020893-2011-00352
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 25, 2011
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BG
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SERVICE REPORT SHOWS THE CUSTOMER REPORTED THAT THE 840 VENTILATOR SHUT DOWN WHEN PLACED ON A PATIENT. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE CSE INSPECTED THE DEVICE AND REPLACED THE POWER SUPPLY. THE UNIT PASSED EXTENDED SELF 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