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

Model Number	A1
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The power management board was replaced to resolve the issue.Block a: patient information could not be obtained due to country privacy laws.Â â  legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.
Event or Problem Description
It was reported that there was an error resulting in power management board failure during a case that does not allow the battery to charge.There was no patient injury.

• Brand Name: CARESTATION 750C
• 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: 21724095
• Report Number: 9710602-2025-00525
• Device Sequence Number: 3808920
• Product Code: BSZ
• UDI-Device Identifier: 00840682146425
• UDI-Public: (01)00840682146425(11)230904
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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: 05/14/2024
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown