BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARESCAPE

    MDR report key: 21091435 · Received January 7, 2025

    Report

    Report Number
    9710602-2025-00039
    Event Type
    Death
    Date Received
    January 7, 2025
    Date of Event
    December 11, 2024
    Report Date
    April 22, 2025
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
    Product Code
    CBK
    PMA / PMN Number
    K210384
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S (GEHC) INVESTIGATION HAS BEEN COMPLETED AND THE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE REVIEW OF THE DEVICE LOGS, PART INSPECTION, LAB TESTING, THE ROOT CAUSE OF THE FAULTY EXPIRATORY FLOW SENSOR WAS DETERMINED TO BE CONTAMINATION DUE TO THE USER NOT USING AN EXPIRATORY FILTER. THIS WOULD ONLY AFFECT THE DISPLAYED VALUES AND NOT DELIVERY. THE ROOT CAUSE OF THE PATIENT DEATH IS UNDETERMINED.

    Additional Manufacturer Narrative · 0

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM BUT DID NOT CONFIRM THE REPORTED ISSUE. 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. D4 PRIMARY UDI NUMBER: THIS DEVICE WAS NOT MANUFACTURED FOR SALE IN THE USA AND THEREFORE A USA UDI IS NOT AVAILABLE. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT CONNECTED TO A CARESCAPE R860 WHEN IT WAS ALLEGED THAT THE UNIT ALARMED FOR LOW TIDAL VOLUME. REPORTEDLY, THE TIDAL VOLUME WAS 120ML, BUT WAS SET FOR 450ML. MANUAL VENTILATION WAS INITIATED CONTINUOUSLY UNTIL IT EXCEEDED THE ALARM UNIT. IT WAS REPORTED THAT RESUSCITATION EFFORTS FAILED AND THE PATIENT DIED. 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
    1347073 CARESCAPE VENTILATOR, CONTINUOUS, FACILITY USE CBK GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) R860 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death