MAUDE Adverse Event Report: Maquet Critical Care AB Servo-i Base Unit; Ventilator, Continuous, Facility Use

Model Number	6487800
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator's support arm was broken.There was no patient involvement.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
On-site investigation was performed by our field service engineer.The claimed issue was reproduced during troubleshooting.According to received information, the replacement of the support arm parts will solve the issue.The support arm serves to relieve the patient from the weight of the tubing system.It is worth mentioning that customer is obliged to follow the installation instructions delivered together with the device.For example, according to installation instructions for the support arm 177 (e.G.Rev.04) in the specification of the maximum capacity, it is stated how many kilograms can be loaded depending on the angle of use of the accessories (max.Approx.3 kg).When moving the support arm or changing position, the patient connection should be observed to see that no pulling or other movement occurs.The cause of the claimed issue in this customer product complaint has been determined.The issue was related to defective joints of support arm.Event site postal code: (b)(6).

• Brand Name: Servo-i 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: 50895629
• Report Number: 8010042-2026-0001326
• Device Sequence Number: 13439722
• Product Code: CBK
• UDI-Device Identifier: 07325710000823
• UDI-Public: (01)07325710000823(11)181206
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K123149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 6487800
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown