BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3940686 · Received June 25, 2014

    Report

    Report Number
    8020893-2014-01490
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 28, 2014
    Manufacturer
    COVIDIE, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE UNIT, AND VERIFIED THE REPORTED MALFUNCTION. THE CSE REPLACED THE GRAPHIC USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB), THE BACKLIGHT INVERTER PRINTED CIRCUIT BOARDS (PCB'S), AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MFG SPECS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PT USE, AN 840 VENTILATOR GRAPHIC USER INTERFACE (GUI) DISPLAY BECAME BLANK, AND IT CONTINUED CYCLING. THE PT WAS REMOVED FROM THE UNIT, AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369560 840 VENTILATOR CBK COVIDIE, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention