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

Model Number	6640440
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	06/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our field service engineer (fse) has investigated the reported ventilator on-site.The fse replaced the o2 gas module to resolve the issue.Following the replacement, the ventilator passed all functional and safety tests and was cleared for clinical use.The o2 gas module regulates the inspiratory gas flow and a faulty o2 gas module may affect the delivered volume or gas mixture (o2/air).The reported issue was confirmed in provided device's logs.No further investigation can be done as the defective o2 gas module will not be returned for investigation.The cause of the reported issue in this customer product complaint has been determined.The issue was related to o2 gas module.
Event or Problem Description
It was reported that the ventilator failed o2 cell/sensor test during pre-use check.There was no patient involvement.Manufacturer's ref.#: (b)(4).

• 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: 25576373
• Report Number: 8010042-2026-0000838
• Device Sequence Number: 20122335
• Product Code: CBK
• UDI-Device Identifier: 07325710001127
• UDI-Public: (01)07325710001127(11)210503
• Combination Product (Y/N): N
• PMA/510(K) Number: K123149
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

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: 6640440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown