BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 1133664 · Received August 20, 2008

    Report

    Report Number
    8020893-2008-00419
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 11, 2008
    Manufacturer
    PURITAN BENNETT CORP.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS CONTACTED FOR MORE INFORMATION, BUT NO RESPONSE TO DATE. THE VENT WAS EVALUATED, AND THE ALLEGED MALFUNCTION WAS NOT DUPLICATED. THE VENTILATOR PASSED ALL TESTING. A FOLLOW UP REPORT WILL BE SUBMITTED, WHEN NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    MHRA HAVE RECEIVED A REPORT, WHICH STATES: VENTILATOR POWER FAILURE. VENT APPEARED TO SWITCH ITSELF OFF AND THEN IMMEDIATELY RESTART WHILST CHANGING VENTILATION PARAMETERS. PATIENT ATTACHED.

    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