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

Model Number	6688600
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during patient treatment, the respiratory rate increased.There was no patient harm.Manufacturer¿s ref #: (b)(4).
Event or Problem Description
Manufacturer¿s ref #: (b)(4).
Additional Manufacturer Narrative
Review of the available text logs and video material identified repeated alarms related to patient circuit disconnected, high respiratory rate, and volume delivery restriction during the reported event.No alarms for elevated etco2 were observed in the provided logs.The available video material suggests increased patient respiratory effort while ventilated in prvc mode, which may indicate that the delivered ventilation was insufficient to fully meet patient demand at the selected settings.In such situations, the ventilator may reduce peak inspiratory pressure to maintain the configured target volume, which can result in increased patient work of breathing if the set tidal volume is too low for the patient¿s needs.Direct comparison with another ventilator is difficult, as ventilation algorithms and pressure/volume delivery strategies may differ between manufacturers, even when similar settings are applied.No comparative recordings or detailed data from the alternative ventilator were available for evaluation.Based on the available information and investigation results, no technical malfunction or evidence of performance deviation of the servo-n ventilator was identified.

• Brand Name: BASE UNIT SERVO-N
• 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: 24543147
• Report Number: 8010042-2026-0000339
• Device Sequence Number: 9239746
• Product Code: CBK
• UDI-Device Identifier: 07325710001042
• UDI-Public: (01)07325710001042(11)251106
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: K201874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 6688600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Sex: Male