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

Model Number	6694800
Medical Device Problem Code	Contamination (1120)
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
The air gas module regulates the inspiratory gas flow and gas mixture.The water in the air gas module as previous investigation has shown, had affected the delta pressure transducer on a printed circuit board inside the air gas module.The delta pressure transducer is part of the flow measuring in the gas module.The failure of the delta pressure transducer leads to inaccurate gas flow regulation which will be detected during pre-use check and alarms will be activated if the failure occurs during ventilation.The conclusion is that the device did not fail to meet its specification, as the most probable source of water in the air gas module is a contaminated air gas from the compressor mini.According to the applicable user's manual, maximum levels of water (h2o < 7 g/m3) in the supplied gases to the ventilator must not be exceeded.Contamination of the air gas module was confirmed by provided photos.The cause of the claimed issue in this customer product complaint has been determined.The issue was related to compressor mini connected to the ventilator.However, no defects or abnormalities were found in the compressor mini.
Event or Problem Description
It was reported that the ventilator's air gas module was contaminated by liquid.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: 25499637
• Report Number: 8010042-2026-0000789
• Device Sequence Number: 10505955
• Product Code: CBK
• UDI-Device Identifier: 07325710001110
• UDI-Public: (01)07325710001110(11)241212
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown