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

Model Number	6882000
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
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.Dc/dc & battery control board, control printed circuit board, battery modules and o2 cell were replaced to resolve the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.Dc/dc & standard connectors printed circuit board convert and supply required internal voltages, control switching between mains power supply and external 12 v battery, and hold a number of standard connectors.Control pcb is part of subsystem breathing bre.Main functions are responsibility for the patient treatment, i.E.How to regulate the inspiratory and expiratory gas flow.Unfortunately, the device¿s logs and faulty parts 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 dc/dc & standard connectors printed circuit board, control printed circuit board, o2 cell and battery modules.
Event or Problem Description
It was reported that during standby the ventilator generated technical error codes indicating power errors and turbine module communication error.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: 25239712
• Report Number: 8010042-2026-0000661
• Device Sequence Number: 15852255
• Product Code: CBK
• UDI-Device Identifier: 07325710003114
• UDI-Public: (01)07325710003114(11)221124
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K192604
• 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): 05/20/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown