BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3223833 · Received July 10, 2013

    Report

    Report Number
    8020893-2013-01526
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 30, 2013
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO STATING THAT DUE TO A VENTILATOR MALFUNCTION PT WAS PLACED ON A SECOND VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE CUSTOMER REPORTED TO HAVE TESTED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED FAILURE. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314954 840 VENTILATOR VENTILATOR CBK COVIDIEN 848

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention