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	05/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the ventilator failed the internal leakage test during the pre-use check.There was no patient involvement.A third-party field service engineer (fse) has investigated the reported ventilator on-site.The fse replaced the air gas module to resolve the issue.Following the replacement, the ventilator passed all functional and safety tests and was cleared for clinical use.The device's logs were not provided for further analysis.The air gas module regulates the inspiratory gas flow and a faulty air gas module may affect the delivered volume or gas mixture (o2/air).The cause of the reported issue in this customer product complaint has been determined.The issue was related to the air gas module.The defective part was not returned for investigation despite our request.According to the information received, it was retained by the customer in accordance with their policy.
Event or Problem Description
It was reported that the ventilator failed the internal leakage test during the 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: 25542470
• Report Number: 8010042-2026-0000815
• Device Sequence Number: 10314974
• Product Code: CBK
• UDI-Device Identifier: 07325710001127
• UDI-Public: (01)07325710001127(11)200519
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown