BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEC 6 PLUS

    MDR report key: 5068358 · Received September 10, 2015

    Report

    Report Number
    2112667-2015-00147
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    August 7, 2015
    Report Date
    August 19, 2015
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CAD
    PMA / PMN Number
    K000275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    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 HOSPITAL REPORTED THAT, DURING THE CASE, THE VAPORIZER WAS PLUGGED INTO A ¿POWER MATE¿, WHICH WAS PLUGGED INTO THE WALL OUTLET. THE HOSPITAL FURTHER REPORTED THAT THE OUTLET IN THE ¿POWER MATE¿ THE VAPORIZER WAS PLUGGED INTO WAS LOOSE AND THE CONNECTION WAS NOT SECURE. THE TEC 6 PLUS MANUAL INSTRUCTS THE USER TO CONNECT THE POWER CORD FROM THE VAPORIZER TO AN APPROVED HOSPITAL GRADE OUTLET SOCKET. THE VAPORIZER WAS BEING USED ON A NONVALIDATED DRAGER ANESTHESIA MACHINE. THE TEC 6 PLUS MANUAL STATES "THE DATEX-OHMEDA VAPORIZER SHOULD BE USED IN ANESTHESIA SYSTEMS EQUIPPED WITH A SELECTATEC SERIES MANIFOLD ONLY". THE VAPORIZER WAS SENT TO GE HEALTHCARE FOR INVESTIGATION. THE UNIT WAS TESTED AND FOUND TO FUNCTION WITHIN MANUFACTURER¿S SPECIFICATIONS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE VAPORIZER WAS MOUNTED ON A NON-VALIDATED DRAGER ANESTHESIA MACHINE. IT WAS FURTHER REPORTED THAT THE VAPORIZER WAS PLUGGED INTO A POWERMATE THAT WAS PLUGGED INTO A WALL OUTLET. THE OUTLET IN THE POWERMATE WAS REPORTEDLY LOOSE (CONNECTION WAS NOT SECURE). THE HOSPITAL STATED THAT, AT SOME POINT DURING THE CASE, THE TEC 6 POWER CORD WAS ACCIDENTALLY KNOCKED OUT OF THE POWERMATE. ACCORDING TO THE ELECTRONIC MEDICAL RECORD (EMR), THE PATIENT DID NOT RECEIVE AGENT FOR OVER AN HOUR. FOLLOWING THE CASE, THE PATIENT REPORTED HAVING RECALL OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598084 TEC 6 PLUS VAPORIZER CAD DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR