BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3812839 · Received May 6, 2014

    Report

    Report Number
    8020893-2014-01035
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE CUSTOMER REPORTED ISSUE. THE CSE REPLACED THE BACKLIGHT PRINTED CIRCUIT BOARD (PCB), WHICH RESOLVED THE CUSTOMER REPORTED ISSUE. THE DEVICE PASSED ALL FUNCTIONAL TESTING. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM (B)(6) STATED AN 830 VENTILATOR EXPERIENCED A "BLACK" SCREEN, WHILE BEING USED ON A PATIENT. THE PATIENT WAS REMOVED FORM THE DEVICE AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271145 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention