BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3980972 · Received July 24, 2014

    Report

    Report Number
    8020893-2014-01799
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 3, 2014
    Manufacturer
    NEWPORT MEDICAL INSTRUMENT
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND BACKLIGHT INVERTER PRINTED CIRCUIT BOARDS (PCB). THE CSE UPGRADED THE SOFTWARE TO THE CURRENT REVISION AND PERFORMED THE EXTENDED SELF-TEST (EST), SHORT SELF-TEST (SST) AND THE PERFORMANCE VERIFICATION TEST (PVT); THE DEVICE OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT AN 840 VENTILATOR HAD IRREGULAR COLORS AND FLICKERING DISPLAY WHILE IN USE ON A PATIENT. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434995 840 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENT 840

    Patients

    Seq Age Sex Outcome Treatment
    1