BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3980990 · Received July 24, 2014

    Report

    Report Number
    8020893-2014-01807
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE OXYGEN SENSOR. THE DEVICE PASSED ALL CALIBRATIONS, SHORT SELF-TEST (SST), EXTENDED SELF-TEST (EST) AND PERFORMANCE VERIFICATION TESTING ACCORDING TO MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT WHILE IN USE ON A PATIENT THE TOP HALF OF THE GRAPHIC USER INTERFACE (GUI) DISPLAY ON AN 840 VENTILATOR WAS BLANK. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435004 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention