BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3810727 · Received March 21, 2014

    Report

    Report Number
    8020893-2014-00668
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 20, 2014
    Manufacturer
    COVIDIEN ,FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY WAS ADVISED TO HAVE THE DEVICE REPAIRED. THE COVIDIEN CUSTOMER SERVICE ENGINEER (CSE) REPLACED THE GRAPHICAL USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) AND DOWNLOADED REV AK SOFTWARE. THE DEVICE OPERATED ACCORDING TO FACTORY SPECIFICATIONS. THE SERVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED FOR SIMILAR COMPLAINT MODES. NO RELEVANT COMPLAINT MODES WERE FOUND IN THE DEVICE SERVICE HISTORY RECORD. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA WITH INFO STATING THAT THE DEVICE UPPER DISPLAY HAD LINES IN IT AND THAT THE USER FACILITY SWAPPED SCREENS FROM ANOTHER DEVICE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169635 840 VENTILATOR CBK COVIDIEN ,FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1