BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3934259 · Received June 27, 2014

    Report

    Report Number
    8020893-2014-01497
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 29, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE UNIT, AND VERIFIED THE REPORTED MALFUNCTION. THE CSE REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB), THE BACKLIGHT INVERTER PRINTED CIRCUIT BOARDS (PCBS), AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PATIENT USE, AN 840 VENTILATOR GRAPHICAL USER INTERFACE (GUI) DISPLAY BECAME INOPERABLE. THE PATIENT WAS REMOVED FROM THE VENTILATOR, AND PLACED ON AN ALTERNATIVE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377348 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention