BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEC

    MDR report key: 21613664 · Received March 15, 2025

    Report

    Report Number
    2112667-2025-02024
    Event Type
    Malfunction
    Date Received
    March 15, 2025
    Date of Event
    February 19, 2025
    Report Date
    May 27, 2025
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CAD
    UDI-DI
    00840682124737
    PMA / PMN Number
    K172702
    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

    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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR CORRECTION IS BEING SUBMITTED TO CORRECT THE H6 CLINICAL CODE. THE INITIAL MDR INDICATE CODE E232401: GASTROINTESTINAL SYSTEM: INCONTINENCE: FECAL INCONTINENCE. THE CORRECT CODE HAS BEEN CHANGED TO E2403: OTHERS: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

    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
    900473 TEC VAPORIZER CAD DATEX-OHMEDA, INC. 850 SEV NA 00840682124737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown