MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESTATION 650C; ANESTHESIA GAS MACHINE

Model Number	A1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distributor performed a checkout of the equipment and confirmed the reported complaint.The flow sensor was replaced to resolve the issue.Block a: patient information could not be obtained due to country privacy laws.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 loss of mechanical ventilation during a case.There was no patient injury.

• Brand Name: CARESTATION 650C
• Common Device Name: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: michaela moore ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 23889145
• Report Number: 2112667-2025-09990
• Device Sequence Number: 20016663
• Product Code: BSZ
• UDI-Device Identifier: 00840682103954
• UDI-Public: (01)00840682103954(11)200228
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/25/2025

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
• Device Catalogue Number: 1012-9655-000
• 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: 11/26/2025
• Initial Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2020
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown