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

Model Number	6487800
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	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On-site investigation was performed by distributor's field service engineer.The claimed issue was reproduced during troubleshooting.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.Pressure transducer pcb measures the pressure, conveyed via the pressure tube connected to this block by its differential pressure transducer.With differential reference to the ambient pressure, the output signal is proportional to the measured pressure thus giving a linear measurement in the range -40 cmh2o to +160 cmh2o.The device's logs were not provided for further analysis.The defective part was not returned for investigation, despite request.The cause of the reported issue in this customer product complaint has been determined.The issue was related to pressure transducer pcb.
Event or Problem Description
It was reported that the ventilator failed internal leakage test during pre-use check.There was no patient involvement.Manufacturer's ref.#: (b)(4).

• Brand Name: SERVO-I 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: 25467915
• Report Number: 8010042-2026-0000773
• Device Sequence Number: 10352678
• Product Code: CBK
• UDI-Device Identifier: 07325710000823
• UDI-Public: (01)07325710000823(11)170927
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: 6487800
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown