MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB BASE UNIT SERVO-U MR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	6694800
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator failed internal leakage test during pre-use check with a message 'system volume too small'.There was no patient involvement.Manufacturer's ref.#: (b)(4).
Event or Problem Description
Manufacturer's ref.#:(b)(4).
Additional Manufacturer Narrative
Our field service engineer investigated the ventilator on-site.The issue was resolved after replacing the air and o2 gas modules.After the replacement, the ventilator passed all functional and safety tests and was cleared for clinical use.No log files were provided.Therefore, it was not possible to verify the reported failure through logs.The air and o2 gas modules regulate the inspiratory gas flow and gas mixture.The faulty gas module may lead to stop of ventilation, low o2 or high pressure.The removed air and o2 gas modules was returned to the manufacturer for further investigation.During the investigation at the manufacturer's site, the returned air and o2 gas modules were installed into a ventilator where testing was performed by simulating multiple pre-use checks, all of which passed successfully.Following this, ventilation was successfully performed for several days without generating any alarms or errors.After ventilation, it passed another pre-use check.The conclusion is that the reported issue could not be reproduced at the manufacturer's site, indicating that the issue may be intermittent.Based on the available information the replaced air and o2 gas modules remains the most probable cause of the reported event.

• Brand Name: BASE UNIT SERVO-U MR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): Maquet Critical Care AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 24673367
• Report Number: 8010042-2026-0000394
• Device Sequence Number: 16023530
• Product Code: CBK
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: 6694800
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2026
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown