BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 5133649 · Received October 7, 2015

    Report

    Report Number
    8020893-2015-01110
    Event Type
    Injury
    Date Received
    October 7, 2015
    Report Date
    September 11, 2015
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED ERROR LOGS INDICATING A LOSS OF COMMUNICATION BETWEEN THE BREATH DELIVERY (BD) UNIT AND THE GRAPHIC USER INTERFACE (GUI). THE CUSTOMER REPORTED THEY WILL HAVE A THIRD PARTY SERVICE REPAIR THE VENTILATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, A VENTILATOR HAD A DEVICE ALERT. THE PATIENT WAS TRANSFERRED TO ANOTHER DEVICE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663316 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention