BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEC 7

    MDR report key: 14053087 · Received April 8, 2022

    Report

    Report Number
    2112667-2022-00822
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    March 11, 2022
    Report Date
    July 22, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CAD
    PMA / PMN Number
    K031027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. PATIENT IDENTIFIER, AGE OR DATE OF BIRTH, WEIGHT, ETHNICITY, AND RACE: INFORMATION UNAVAILABLE AT TIME OF MDR FILING. LEGAL MANUFACTURER: HCS (B)(4).

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION, DUE TO THE VAPORIZER NOT BEING ABLE TO BE SENT BACK FOR ANALYSIS. THE MOST LIKELY ROOT CAUSES ARE THE FOLLOWING: ¿¢ AGENT BOTTLE ADAPTER LEAK OR FAULTY FILLER. THE TEC 7 DEVICE IS UNAVAILABLE FOR ANALYSIS TO DETERMINE IF THE FILLER CAP WAS DAMAGED OR THE FILLER PORT SCREWS MAY HAVE BEEN INSUFFICIENTLY ENGAGED. ¿¢ DRAIN PLUG OR VAPORIZER LEAKAGE. THE TEC 7 DEVICE IS UNAVAILABLE FOR ANALYSIS TO DETERMINE IF THE DRAIN PLUG WAS DAMAGED OR LOOSE. ¿¢ LEAK OF FRESH GAS BY SEALS IN LOW PRESSURE SIDE OF VAPORIZER OR CONNECTION TO BACK BAR. THE TEC 7 DEVICE IS UNAVAILABLE FOR ANALYSIS TO EXAMINE THE SEALS AT THE REAR OF THE TEC 7 FOR LEAKS, AND TO EXAMINE THE CONNECTION TO THE SELECTATEC BACKBAR. ¿¢ PATIENT DISCONNECTED, BREATHING CIRCUIT OPEN TO ATMOSPHERE. THE USERS WERE BEGINNING INDUCTION AT THE TIME OF THE EVENT. DURING THIS TIME, THE PATIENT HAS YET TO BE CONNECTED TO THE ANESTHESIA DEVICE AND THE BREATHING CIRCUIT IS OPEN. ¿¢ VAPORIZER SUMP (LIQUID AGENT RESERVOIR) LEAK, DAMAGED SUMP, OR SEAL. THE TEC 7 DEVICE IS UNAVAILABLE FOR ANALYSIS TO DETERMINE IF THE SUMP OR SEAL WAS DAMAGED. H3 OTHER TEXT : THE ROOT CAUSE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION, DUE TO THE VAPORIZER NOT BEING ABLE TO BE SENT BACK FOR ANALYSIS. THE MOST LIKELY ROOT CAUSES ARE THE FOLLOWING: ¿¢ AGENT BOTTLE ADAPTER LEAK OR FAULTY FILLER. THE TEC 7 DEVICE IS UNAVAILABLE FOR ANALYSIS TO DETERMINE IF THE FILLER CAP WAS DAMAGED OR THE FILLER PORT SCREWS MAY HAVE BEEN INSUFFICIENTLY ENGAGED. ¿¢ DRAIN PLUG OR VAPORIZER LEAKAGE. THE TEC 7 DEVICE IS UNAVAILABLE FOR ANALYSIS TO DETERMINE IF THE DRAIN PLUG WAS DAMAGED OR LOOSE. ¿¢ LEAK OF FRESH GAS BY SEALS IN LOW PRESSURE SIDE OF VAPORIZER OR CONNECTION TO BACK BAR. THE TEC 7 DEVICE IS UNAVAILABLE FOR ANALYSIS TO EXAMINE THE SEALS AT THE REAR OF THE TEC 7 FOR LEAKS, AND TO EXAMINE THE CONNECTION TO THE SELECTATEC BACKBAR. ¿¢ PATIENT DISCONNECTED, BREATHING CIRCUIT OPEN TO ATMOSPHERE. THE USERS WERE BEGINNING INDUCTION AT THE TIME OF THE EVENT. DURING THIS TIME, THE PATIENT HAS YET TO BE CONNECTED TO THE ANESTHESIA DEVICE AND THE BREATHING CIRCUIT IS OPEN. ¿¢ VAPORIZER SUMP (LIQUID AGENT RESERVOIR) LEAK, DAMAGED SUMP, OR SEAL. THE TEC 7 DEVICE IS UNAVAILABLE FOR ANALYSIS TO DETERMINE IF THE SUMP OR SEAL WAS DAMAGED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED AN OPERATING ASSISTANT FELL AND HAD CONVULSIONS AFTER A LEAK OF SEVOFLURANE ANESTHESIA GAS FROM A TEC 7 VAPORIZER DURING INTUBATION OF A PATIENT. ALLEGEDLY, THE OPERATING ASSISTANT WAS TAKEN TO THE HOSPITAL FOR A SCAN OF HER COCCYX BONE WHICH WAS NEGATIVE, AND A CHECK OF RED AND WHITE CELLS WAS HIGH. THE TEC 7 VAPORIZER INVOLVED IN THE EVENT WAS REPORTED LOST BY THE CUSTOMER. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155867 TEC 7 VAPORIZER CAD DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female