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

Model Number	6688600
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator failed internal leakage test and pressure transducer test during pre-use check.There was no patient involvement.Manufacturer's ref.#: (b)(4).

• Brand Name: BASE UNIT SERVO-N
• 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: 24893389
• Report Number: 8010042-2026-0000518
• Device Sequence Number: 21082280
• Product Code: CBK
• UDI-Device Identifier: 07325710001042
• UDI-Public: (01)07325710001042(11)200801
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 6688600
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown