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

Model Number	6694800
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
On-site investigation was performed by the field service engineer.According to received information, the replacement of the support arm is required to resolve the issue.The support arm serves to relieve the patient from the weight of the tubing system.According to the information received during the processing of the complaint, the arm was pulled to move the ventilator system.Therefore, the most probable cause of the issue is considered to be the user not following the instructions.

• 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: 50138275
• Report Number: 8010042-2026-0001064
• Device Sequence Number: 18421782
• Product Code: CBK
• UDI-Device Identifier: 07325710001110
• UDI-Public: (01)07325710001110(11)210208
• Combination Product (Y/N): N
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown