BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEC 6 PLUS

    MDR report key: 21461058 · Received February 25, 2025

    Report

    Report Number
    2112667-2025-01313
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    January 29, 2025
    Report Date
    March 1, 2025
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CAD
    UDI-DI
    00840682115902
    PMA / PMN Number
    K000275
    Removal / Correction Number
    Z-0814-2025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO REPAIR INFORMATION AVAILABLE. THE INITIAL MDR INCORRECTLY REPORTED THAT THE DEVICE WAS PART OF A RECALL NO. Z-0814-2025. THIS SUPPLEMENTAL MDR CORRECTION IS BEING FILED TO CORRECT THE B5 EVENT DESCRIPTION, CORRECT AND UPDATE H6 CODING, REMOVE RECALL INFORMATION FROM THE H7 AND H9, AND CORRECT H11 ADDITIONAL NARRATIVE.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT PER 21 CFR 806 ON 27-NOV-2024. THE FDA RECALL NUMBER IS (RECALL NO. Z-0814-2025). CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND INSTRUCTIONS FOR INSPECTING FOR CORRECT OUTPUT CONCENTRATION. GEHC WILL REPLACE ALL AFFECTED UNITS. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN POTENTIAL AGENT DELIVERY LESS THAN 20% FROM THE SETTING. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 27-NOV-2024, (RECALL NO. Z-0814-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095796 TEC 6 PLUS VAPORIZER CAD DATEX-OHMEDA, INC. NA 00840682115902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown