BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3943546 · Received April 30, 2014

    Report

    Report Number
    8020893-2014-01013
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    March 31, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) ASSISTED THE USER FACILITY WITH TROUBLESHOOTING THE DEVICE VIA PHONE. THE USER FACILITY REPORTED, THE ERROR WAS UNABLE TO BE DUPLICATED. THE USER FACILITY REPORTEDLY RETURNED TO THE VENTILATOR TO CLINICAL USE FOLLOWING A 48 HOUR OPERATIONAL TEST ON A MANUFACTURED LUNG WITHOUT INCIDENT. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED A DEVICE ALERT WHICH RENDERED THE VENTILATOR INOPERABLE. IT WAS REPORTED, THE EVENT OCCURRED WHILE SETTING UP FOR PATIENT USE. THE DEVICE WAS REMOVED FROM CLINICAL USE AND THE HOSPITAL'S BIOMED DEPARTMENT WAS NOTIFIED OF THE EVENT. THE HOSPITAL'S BIOMED TECHNICIAN STATED THE ERROR COULD HAVE POSSIBLY BEEN DUE TO USER ERROR. THE DATE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258701 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1