MAUDE Adverse Event Report: Maquet Critical Care AB Servo-s Base Unit; Ventilator, Continuous, Facility Use

Model Number	6640440
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during patient ventilation, ventilator generated an o2 sensor failure alarm while connecting to an o2 concentrator.Patient's saturation decreased to unknown level.The ventilator was replaced.Final patient outcome was no harm.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
Note: this event contains both an adverse event and a product problem.Due to a temporary system limitation associated with recent fda emdr system enhancements, only the adverse event designation could be transmitted in the current submission.Product problem details are included within this report.A supplemental mdr will be submitted once the emdr utility has been updated to support transmission of both event classifications.

• Brand Name: Servo-s Base Unit
• 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: 50898137
• Report Number: 3013876692-2026-00110
• Device Sequence Number: 18817838
• Product Code: CBK
• UDI-Device Identifier: 07325710001127
• UDI-Public: (01)07325710001127(11)200723
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026
• Report Date (Section F): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 6640440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/09/2026
• Device Age: 6 YR
• Date Report to Manufacturer: 09/25/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/25/2026