BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE

    MDR report key: 22715901 · Received August 5, 2025

    Report

    Report Number
    2112667-2025-06286
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 16, 2025
    Report Date
    January 2, 2026
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    UDI-DI
    00840682102346
    PMA / PMN Number
    K210384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A: PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE BATTERY ALARMED PRE-MATURELY. THIS IS NOT A REPORTABLE MALFUNCTION. THERE WAS NO FAILURE OF THE BATTERY. H6 MEDICAL DEVICE PROBLEM CODE UPDATED TO A160106.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2497525 CARESCAPE VENTILATOR, CONTINUOUS, FACILITY USE CBK DATEX-OHMEDA, INC. R860 NA 00840682102346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown