BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESCAPE

    MDR report key: 23356462 · Received October 22, 2025

    Report

    Report Number
    2112667-2025-08259
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 23, 2025
    Report Date
    February 2, 2026
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    UDI-DI
    00840682102346
    PMA / PMN Number
    K210384
    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'S (GEHC) INVESTIGATION HAS BEEN COMPLETED AND THE ROOT CAUSE COULD NOT BE DETERMINED. NEITHER THE DEVICE LOGS NOR THE GEHC FIELD ENGINEER INSPECTION IDENTIFIED ANY SOURCE OF MALFUNCTION. IT IS LIKELY THAT THE CAUSE OF THE DROP IN OXYGEN SATURATION WAS ENDOTRACHEAL (ET) TUBE DISCONNECTION WHILE MOBILIZING THE PATIENT DURING HYGIENE CARE. NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A: NO PATIENT INFORMATION PROVIDED TO DATE. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS CONNECTED TO A CARESCAPE R860 WHEN IT WAS ALLEGED THAT THE PATIENT DESATURATED. THE LEVEL OF DESATURATION WAS NOT REPORTED. THERE WERE NO PATIENT SEQUELAE REPORTED. 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
    285417 CARESCAPE VENTILATOR, CONTINUOUS, FACILITY USE CBK DATEX-OHMEDA, INC. R860 NA 00840682102346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other