BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEC 7

    MDR report key: 5999523 · Received October 5, 2016

    Report

    Report Number
    2112667-2016-01948
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 6, 2016
    Report Date
    December 5, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CAD
    PMA / PMN Number
    K012924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE?S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED AND FOUND TO FUNCTION WITHIN MANUFACTURER¿S SPECIFICATIONS. THE REPORTED COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING A CASE, THE PATIENT STARTED TO WAKE UP. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652929 TEC 7 VAPORIZER CAD DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR