BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7200

    MDR report key: 2221306 · Received August 16, 2011

    Report

    Report Number
    2221306
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 16, 2011
    Manufacturer
    COVIDIEN PURITAN-BENNETT
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR POWERED-OFF AND IMMEDIATELY POWERED BACK ON. THE VENTILATOR WAS CHANGED AND THERE WAS NO PATIENT HARM, INJURY, OR ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7200 VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN PURITAN-BENNETT 7200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR