BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE R860

    MDR report key: 25055921 · Received May 1, 2026

    Report

    Report Number
    9710602-2026-01212
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 3, 2026
    Report Date
    May 22, 2026
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD
    Product Code
    CBK
    PMA / PMN Number
    K210384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 REPORT OF PATIENT INVOLVEMENT. 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

    IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115268 CARESCAPE R860 VENTILATOR, CONTINUOUS, FACILITY USE CBK GE MEDICAL SYSTEMS (CHINA) CO., LTD NA

    Patients

    Seq Age Sex Outcome Treatment
    1