BEUDAMED
    FDA Adverse Event Death Summary report: N

    840 VENTILATOR

    MDR report key: 6175036 · Received December 15, 2016

    Report

    Report Number
    8020893-2016-03467
    Event Type
    Death
    Date Received
    December 15, 2016
    Report Date
    November 17, 2016
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, DURING PATIENT USE, AN 840 VENTILATOR WAS VENTILATING NORMALLY, WHEN THE PATIENT WAS REMOVED FROM THE VENTILATOR. THE PATIENT WAS REMOVED FROM THE VENTILATOR FOR TRANSPORT TO ANOTHER FACILITY FOR SURGERY. THE CUSTOMER REPORTED THAT LATER THE PATIENT EXPIRED. THE CUSTOMER REPORTED THAT THE VENTILATOR DID NOT CONTRIBUTE TO THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827361 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Death