BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3823364 · Received February 19, 2014

    Report

    Report Number
    8020893-2014-00417
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REF NUMBER: (B)(4). THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE CUSTOMER REPORTED PROBLEM. THE CSE REPLACED THE GRAPHICAL USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (SPU) PRINTED CIRCUIT BOARD (PCB), BACKLIGHT INVERTER PRINTED CIRCUIT BOARDS (PCB'S), LATCH, AND HOUSING, WHICH RESOLVED THE CUSTOMER REPORTED ISSUE. THE UNIT PASSED CALIBRATIONS AND EXTENDED SELF-TESTING.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO OF VENTILATOR DISPLAY BEING BLANK. THE MALFUNCTION DID NOT OCCUR DURING PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105516 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1