BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEC

    MDR report key: 21290582 · Received February 3, 2025

    Report

    Report Number
    2112667-2025-00666
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 7, 2025
    Report Date
    March 3, 2025
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CAD
    UDI-DI
    00840682124751
    PMA / PMN Number
    K172702
    Removal / Correction Number
    Z-0814-2025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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

    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.

    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
    2088673 TEC VAPORIZER CAD DATEX-OHMEDA, INC. 850 ISO NA 00840682124751

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown