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

Model Number	6694800
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	05/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On-site investigation was performed by our field service engineer.The claimed issue was reproduced during troubleshooting.According to received information in service report, replacement of the maintenance kit including nozzle units solved the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.The nozzle unit is part of the gas module and regulates the inspiratory gas flow to the patient.It consists of a membrane, a mouthpiece and a feather spring.The membrane in the nozzle unit is pressed against a mouthpiece with a feather spring to regulate the gas flow through the gas module.According to the manufacturer¿s specification the complete plastic nozzle unit must be replaced during preventive maintenance.Based on information provided by technician, preventive maintenance had not yet been performed as the unit was only 2 months old at the day of event.The reported issue was confirm in provided device's logs.The defective nozzle unit have not been returned fot the further investigation, despite request.The cause of the claimed issue in this customer product complaint has been determined.The issue was related to defective maintenance kit, including nozzle units.
Event or Problem Description
It was reported that the ventilator failed internal leakage test during pre-use check.There was no patient involvement.Manufacturer's ref.#: (b)(4).

• 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: 25441734
• Report Number: 8010042-2026-0000764
• Device Sequence Number: 21198540
• Product Code: CBK
• UDI-Device Identifier: 07325710001110
• UDI-Public: (01)07325710001110(11)260313
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• 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: 6694800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown