BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3946345 · Received July 10, 2014

    Report

    Report Number
    8020893-2014-01654
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 13, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY COVIDIEN. THE EVALUATION AND REPAIR IS EXPECTED, BUT HAS NOT BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT DURING PATIENT USE, AN 840 VENTILATOR GRAPHIC USER INTERFACE (GUI) EXPERIENCED AN ERRATIC DISPLAY. THE PATIENT WAS REMOVED FROM THE UNIT, AND TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404383 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention