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

Model Number	6640440
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On-site investigation was performed.The claimed issue was reproduced during troubleshooting.According to received service report, adjustment of expiratory channel printed circuit board (pcb) solved the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.Valves disabled alarm shall be triggered when a low level of the signal disable_valves.L is detected during a period longer than 11.0 ± 0.1s (the valves_disabled signal has stopped power supply to gas modules and safety valve).This can happen if the breathing subsystem is not working properly or deliberately has shut down the ventilation due to internal problems.Expiratory channel board contains electronics including microprocessor for handling of expiratory flow measurement performed by the flowmeter inside the cassette, all electronic connections to and from the cassette, expiratory valve control, safety valve control, temperature monitoring and also holders and electrical connectors for the expiratory and inspiratory pressure transducer boards.The device's logs were not provided for further analysis.The cause of the claimed issue in this customer product complaint has been determined.The issue was related to expiratory channel pcb.
Event or Problem Description
It was reported that the ventilator generated a technical error code indicating disabled valves.There was no patient harm.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: 25357210
• Report Number: 8010042-2026-0000716
• Device Sequence Number: 10613456
• Product Code: CBK
• UDI-Device Identifier: 07325710001127
• UDI-Public: (01)07325710001127(11)190703
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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: 05/07/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown