BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3851775 · Received April 11, 2014

    Report

    Report Number
    8020893-2014-00886
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Report Date
    March 14, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN TECHNICAL SUPPORT SERVICES (TSS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING THE DEVICE VIA PHONE. TSS RECOMMENDATIONS WERE TO REPLACE THE GUI CENTRAL PROCESSING UNIT (CPU). THE CUSTOMER, REPORTEDLY, WILL BE CONTACTING A THIRD PARTY VENDOR FOR REPAIRS. COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR RECEIVED A DEVICE ALERT TO RESET THE GRAPHICAL USER INTERFACE (GUI) DURING SERVICE. THE DATE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221226 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1