BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4173837 · Received October 15, 2014

    Report

    Report Number
    8020893-2014-02354
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 5, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE GRAPHIC USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB), BACKLIGHT INVERTER PRINTED CIRCUIT BOARD (PCBS) AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRIOR MEDWATCH REPORT WAS SENT IN ERROR. THE EVENT INVOLVED IN THIS COMPLAINT IS NOT A REPORTABLE EVENT. PLEASE REPROCESS THIS REPORT NUMBER TO NOT BE A REPORTABLE EVENT.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT THE GRAPHIC USER INTERFACE (GUI) DISPLAY ON AN 840 VENTILATOR WAS UNREADABLE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654445 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1