BEUDAMED
    FDA Adverse Event Death Summary report: N

    840 VENTILATOR

    MDR report key: 7165242 · Received January 4, 2018

    Report

    Report Number
    8020893-2018-00006
    Event Type
    Death
    Date Received
    January 4, 2018
    Date of Event
    December 25, 2017
    Report Date
    January 4, 2018
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN/MEDTRONIC HAS NOT RECEIVED THE DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. THE SERIAL NUMBER OF THE VENTILATOR WAS NOT PROVIDED, THEREFORE NO DEVICE MANUFACTURING DATE IS AVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CUSTOMER DID NOT REPORT ANY FAILURE WITH THE UNIT WHILE CONNECTED TO PATIENT. PATIENT DIED WHILE ON VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7762 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Death