BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3894145 · Received February 6, 2014

    Report

    Report Number
    8020893-2014-00306
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 10, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE CUSTOMER REPORTED PROBLEM. THE CSE REPLACED THE GRAPHIC USER INTERFACE (GUI) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND BACKLIGHT INVERTER PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED EXTENDED SELF-TESTING.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION OF VENTILATOR WITH A ERRATIC DISPLAY. THE MALFUNCTION ID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78829 840 VENTILATOR CBK; VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1