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

Model Number	6882000
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	04/02/2026
Type of Reportable Event	Malfunction
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 pressure transducer printed circuit board (pcb) solved the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.The defective part has been requested for investigation.The device's logs were not provided for further analysis.
Event or Problem Description
It was reported that the ventilator failed pressure transducer test during pre-use check.There was no patient involvement.Manufacturer's ref.#: (b)(4).

• 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: 25135244
• Report Number: 8010042-2026-0000612
• Device Sequence Number: 18493360
• Product Code: CBK
• UDI-Device Identifier: 07325710003114
• UDI-Public: (01)07325710003114(11)210323
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192604
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: 04/28/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown