MAUDE Adverse Event Report: GE Medical Systems (china) co., Ltd Carestation 620; Anesthesia Gas Machine

Model Number	A1
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was an error that results in an inability to initiate mechanical ventilation.There was no patient injury.
Additional Manufacturer Narrative
The flow sensor was calibrated by the end user which resolved the issue.There was no ge healthcare repair.Block a: no report of patient involvement.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.

• Brand Name: Carestation 620
• Common Device Name: Anesthesia Gas Machine
• Manufacturer (Section D): GE Medical Systems (china) co., Ltd; no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• Manufacturer (Section G): GE Medical Systems (china) co., Ltd; no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• Manufacturer Contact: michaela moore ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 50895572
• Report Number: 9710602-2026-02399
• Device Sequence Number: 10761858
• Product Code: BSZ
• UDI-Device Identifier: 00840682103985
• UDI-Public: (01)00840682103985(11)200715
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151570
• 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): 09/25/2026

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
• Device Catalogue Number: 1012-9620-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown