BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3812838 · Received May 6, 2014

    Report

    Report Number
    8020893-2014-01099
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 8, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND INSPECTED THE DEVICE AND REPLACED THE PROPORTIONAL SOLENOID VALVE ASSEMBLY (PSOL). THE VENTILATOR THEN PASSED EXTENDED SELF-TESTING AND WAS PLACED BACK IN SERVICE. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) STATING THAT AN 840 VENTILATOR EXPERIENCED A MALFUNCTION. THE VENTILATOR STOPPED CYCLING WHILE IN USE ON A PATIENT. THE PATIENT WAS REMOVED FORM THE VENTILATOR AND PLACE ON A SECOND VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271667 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention