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

Model Number	6640440
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator had a leakage.There was no patient harm.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
According to the information provided by the technician, the device was switched as soon as the issue was noticed.It was confirmed that the leak was at inspiratory pipe site.The device was serviced by third party.Information about repair was not provided.Unfortunately, the device¿s logs were not available for further analysis.The cause of the claimed issue in this customer product complaint has been determined.The issue was related to inspiratory pipe.# e1 event site telephone: (b)(4).

• Brand Name: SERVO-S 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: 25649997
• Report Number: 8010042-2026-0000885
• Device Sequence Number: 5903337
• Product Code: CBK
• UDI-Device Identifier: 07325710001127
• UDI-Public: (01)07325710001127(11)210308
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: 6640440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown