BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3913113 · Received May 14, 2014

    Report

    Report Number
    8020893-2014-01148
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Report Date
    April 16, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE GUI CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB). THE DEVICE THEN PASSED THE EXTENDED SELF-TEST (EST) AND PERFORMANCE VERIFICATION TEST (PVT). COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA STATING THAT AN 80 VENTILATOR EXPERIENCED A MALFUNCTION. THE CUSTOMER STATED THAT THE VENTILATOR HAD AN ERRATIC GRAPHICAL USER INTERFACE (GUI) DISPLAY. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED. THE DATE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288039 840 VENTILATOR 840 CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1