BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3897156 · Received May 21, 2014

    Report

    Report Number
    8020893-2014-01224
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Report Date
    April 24, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED TO HAVE REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB). THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) UPLOADED THE OPERATIONAL SOFTWARE ONLY AND PERFORMED THE DEVICE EVALUATION. THE VENTILATOR PASSED THE EXTENDED SELF-TEST (EST), SHORT SELF-TEST (SST) AND THE PERFORMANCE VERIFICATION TEST (PVT); THE DEVICE OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. COVIDIEN REFERENCE (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION FROM A CUSTOMER IN THE USA STATING THAT AN 840 VENTILATOR HAD AN ERRATIC DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED. THE EXACT DATE OF THE INCIDENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304007 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1