BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 1812380 · Received August 17, 2010

    Report

    Report Number
    8020893-2010-00413
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 10, 2010
    Report Date
    July 19, 2010
    Manufacturer
    PURITAN BENNETT CORP.
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    RECEIVED INFORMATION THAT FREQUENCY SETTING WAS CHANGED; VENTILATOR ALARMED AND STOPPED CYCLING WHILE IN PATIENT USE. PATIENT BECAME CYANOTIC AND ALTERNATIVE VENTILATION WAS PROVIDED.

    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 Required Intervention