BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEC 6 PLUS

    MDR report key: 2201323 · Received August 3, 2011

    Report

    Report Number
    2112667-2011-00041
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 7, 2011
    Report Date
    August 3, 2011
    Manufacturer
    DATEX-OHMEDA INC.
    Product Code
    CAD
    PMA / PMN Number
    K000275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A SITE REPORTED A LIGHT ANESTHESIA CASE. THE USERS SWITCHED TO AN ALTERNATE AGENT TO FINISH THE CASE. A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE VAPORIZER AND FOUND IT TO FAIL THE LEAK TEST. THERE WAS NO REPORTED PT INJURY. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEC 6 PLUS ANESTHESIA VAPORIZER CAD DATEX-OHMEDA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR