BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4221939 · Received November 3, 2014

    Report

    Report Number
    8020893-2014-02441
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SERVICE ENGINEER HAS BEEN DISPATCHED AND SERVICE IS PENDING. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A SERVICE CALL FOR "DISPLAY BLANK" ON AN 840 VENTILATOR. CUSTOMER WAS ASKED, HOWEVER, THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701427 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1