BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE

    MDR report key: 24798028 · Received April 7, 2026

    Report

    Report Number
    9710602-2026-00921
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 7, 2026
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD
    Product Code
    CBK
    UDI-DI
    00840682102346
    PMA / PMN Number
    K210384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE FLOW CONTROL VALVE WAS REPLACED TO RESOLVE THE ISSUE. 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 INSUFFICIENT O2 DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864301 CARESCAPE VENTILATOR, CONTINUOUS, FACILITY USE CBK GE MEDICAL SYSTEMS (CHINA) CO., LTD R860 NA 00840682102346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown