BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESCAPE

    MDR report key: 21102201 · Received January 8, 2025

    Report

    Report Number
    2112667-2025-00162
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    December 10, 2024
    Report Date
    June 5, 2025
    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
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE (GEHC) INVESTIGATION HAS BEEN COMPLETED AND THE ROOT CAUSE WAS IDENTIFIED AS USER ERROR. BASED ON THE DEVICE LOG REVIEW BY ENGINEERING, ONSITE QUESTIONNAIRE, FOLLOW UP QUERIES WITH HOSPITAL BIOMED AND THE FE REVIEW OF SYSTEM CHECKOUT AND CALIBRATIONS CONFIRMED THAT THERE WAS NO MALFUNCTION OF THE DEVICE IDENTIFIED. THE END USER RESUMED THE SBT FIO2 AT THE 50% SETTING INSTEAD OF ADJUSTING TO FIO2 OF 100% FOR MECHANICAL VENTILATION WHICH CAUSED PATIENT DESATURATION TO LESS THAN 40%. ADDITIONAL INFORMATION: BLOCK A3 INFORMATION PROVIDED. NO OTHER PATIENT INFORMATION GIVEN.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT WAS CONNECTED TO A CARESCAPE R860 WHEN IT WAS ALLEGED THAT THE OXYGEN PERCENTAGE WAS SET TO 100%, BUT DECREASED TO 50%. IT WAS ALLEGED THAT THE PATIENT DESATURATED TO THE 30% RANGE. THERE WAS NO PATIENT SEQUELAE. 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
    1347767 CARESCAPE VENTILATOR, CONTINUOUS, FACILITY USE CBK DATEX-OHMEDA, INC. R860 NA 00840682102346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other