MAUDE Adverse Event Report: Maquet Critical Care AB BASE UNIT SERVO-U; Ventilator, Continuous, Facility Use

Model Number	6694800
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Manufacturer ref.No: (b)(4).
Additional Manufacturer Narrative
It was reported that the device generated a technical error code indicating a power error.There was no patient harm.The field service engineer reported that the issue was resolved by replacing the monitoring printed circuit board (pcb).Preventive maintenance, full calibration, functional testing, and safety verification were performed in accordance with factory specifications.The device passed all functional and safety tests and was returned to the customer.Inspection of the returned monitoring pcb showed no anomalies.Evaluation of the received device logs confirmed a single occurrence of the reported power error on (b)(6) 2026, which corresponds to the reported event date.When tested in a reference ventilator, three pre-use checks passed, and more than 4.5 days of simulated ventilation testing were completed without any observed deficiencies.An internal power error may result in a loss of ventilation.According to the service manual, the reported power error is typically associated with the dc/dc & standard connectors pcb or the gas modules.The monitoring subsystem incorporates alarm and monitoring functions, and alarms are generated when this fault condition occurs.The reported fault was confirmed in the device logs but could not be reproduced during the investigation.Consequently, no assignable root cause could be identified.

• Brand Name: BASE UNIT SERVO-U
• 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: 50081820
• Report Number: 8010042-2026-0001033
• Device Sequence Number: 16142488
• Product Code: CBK
• UDI-Device Identifier: 07325710001110
• UDI-Public: (01)07325710001110(11)210603
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K201874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2026

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: 6694800
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown