MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 750; ANESTHESIA GAS MACHINE

Model Number	A1
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As a result of an inspection that was completed as part of the correction initiated by ge healthcare (gehc) on 02-apr-2025, (gehc field action number 34142) this unit was identified as having an issue that prevents effective mechanical ventilation in volume control ventilation (vcv) mode.There was no patient involvement.
Additional Manufacturer Narrative
Ge healthcare (gehc) reported a field modification for an issue that prevents effective mechanical ventilation in volume control ventilation (vcv) mode per 21 cfr 806 on 02-apr-2025.The fda recall numbers are: z-1624-2025, z-1625-2025, z-1626-2025, z-1627-2025, z-1628-2025, z-1629-2025, z-1630-2025, z-1631-2025, z-1632-2025, z-1633-2025, z-1634-2025, z-1635-2025, z-1636-2025, z-1637-2025, z-1638-2025.Customers were sent a letter explaining the issue and providing instructions for inspecting for effective ventilation in volume control ventilation (vcv) mode.Gehc will correct all devices that fail the ventilation screening test at no cost.Block a: no patient involvement.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.

• Brand Name: CARESTATION 750
• Common Device Name: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• Manufacturer (Section G): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 21982884
• Report Number: 9710602-2025-00829
• Device Sequence Number: 8572687
• Product Code: BSZ
• UDI-Device Identifier: 00840682146425
• UDI-Public: (01)00840682146425(11)241030
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K213867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: SEE H11
• Patient Sequence Number: 1
• Patient Sex: Unknown