BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEC

    MDR report key: 20247184 · Received September 18, 2024

    Report

    Report Number
    2112667-2024-05104
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 23, 2024
    Report Date
    October 28, 2024
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBZ
    UDI-DI
    00840682124737
    PMA / PMN Number
    K172702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DECLINED SERVICE. NO REPAIR INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    A GE HEALTHCAREÂS INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO REPAIR INFORMATION AVAILABLE. 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 AGENT DELIVERED LESS THAN 20% FROM SETTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227254 TEC VAPORIZER CBZ DATEX-OHMEDA, INC. 850 SEV 00840682124737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown