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

Model Number	6882000
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ventilator generated technical error indicating turbine module communication error.There was no patient harm.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
Event site name: (b)(6).

• Brand Name: Base unit, Servo-air
• 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: 50895353
• Report Number: 8010042-2026-0001322
• Device Sequence Number: 10706133
• Product Code: CBK
• UDI-Device Identifier: 07325710003114
• UDI-Public: (01)07325710003114(11)200909
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K192604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• 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: 6882000
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown