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

Model Number	6640440
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator generated alarms for o2 concentration.There was no patient harm.Manufacturer's ref #: (b)(4).
Additional Manufacturer Narrative
No ventilator logs were provided, and no evaluation of the ventilator was requested.The healthcare facility contacted a third-party service provider for repair and have not disclosed any further information about the current status of the ventilator.As no device evaluation or log analysis could be performed, an investigation was not possible.Therefore, the root cause of the reported fluctuating oxygen concentration could not be determined.

• 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: 25439397
• Report Number: 8010042-2026-0000762
• Device Sequence Number: 6038985
• Product Code: CBK
• UDI-Device Identifier: 07325710001127
• UDI-Public: (01)07325710001127(11)210920
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown