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

Model Number	6487800
Medical Device Problem Codes	Mechanical Problem (1384); Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator failed pressure transducer test and internal leakage test during pre-use check.There was no patient involvement.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
On-site investigation was performed by the distributor's field service engineer.The claimed issue was reproduced during troubleshooting.According to received information in service report, the replacement of the nozzle units on air and o2 gas modules solved the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.The device's logs and the claimed parts were not provided for further analysis.Information provided by technician in communication box confirmed that the nozzle units had broken feather springs.The nozzle unit is part of the gas module and regulates the inspiratory gas flow to the patient.It consists of a membrane, a mouthpiece and a feather spring.The membrane in the nozzle unit is pressed against a mouthpiece with a feather spring to regulate the gas flow through the gas module.If the feather spring is broken, gas will leak into the patient circuit causing failures in the pre-use check and during ventilation a high-pressure alarm will be generated if user set limit is exceeded.The nozzle unit has a predetermined lifetime and is replaced at preventive maintenance that must be performed every 5000 hours of operation or at least once a year.It remains unknown, when the nozzle units were last replaced.The conclusion is that the ventilator failed to meet its specifications.The nozzle units are the cause of the issue due to broken feather springs on the nozzle units.

• 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: 25585409
• Report Number: 8010042-2026-0000843
• Device Sequence Number: 12187436
• Product Code: CBK
• UDI-Device Identifier: 07325710000823
• UDI-Public: (01)07325710000823(11)210531
• 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): 06/22/2026

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: 06/02/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown