BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3223841 · Received July 10, 2013

    Report

    Report Number
    8020893-2013-01546
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    May 26, 2013
    Report Date
    June 10, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THAT DUE TO A MALFUNCTION, THE PATIENT WAS REMOVED FROM THE VENTILATOR. THE PATIENT WAS PLACED ON A SECOND VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316206 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention