BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2110022 · Received April 28, 2011

    Report

    Report Number
    8020893-2011-00210
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 30, 2011
    Manufacturer
    PURITAN BENNETT CORP.
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN WAS NOT AUTHORIZED TO EVALUATE THE DEVICE. COVIDIEN IS TRYING TO CONFIRM WHAT TYPE OF CIRCUIT WAS IN USE AT THE TIME OF THE REPORTED EVENT AND WHETHER A PRE TEST WAS PERFORMED PRIOR TO PT USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING WHILE IN USE ON A PT. ACCORDING TO THE REPORT, "PT IN HDU ON VENTILATOR AND VENTILATOR ALARMING. NOT VENTILATING AND SHOWING DB TUV FAILED. PT WAS PLACED ON WATERS CIRCUIT 100%. VENTILATOR CHANGED. FAULTY VENT CHECKED - LOCKED OUT AND WOULD NOT ALLOW RESET. EQUIPMENT QUARANTINED." THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THIS ISSUE IS STILL UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK PURITAN BENNETT CORP. 840

    Patients

    Seq Age Sex Outcome Treatment
    1