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

Model Number	6882000
Medical Device Problem Codes	Infusion or Flow Problem (2964); 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
The ventilator was investigated by distributor's field service engineer.During on-site visit, additional issue with no ventilation occurred, although gas supplies were available and an internal power failure alarm sounded.Battery extension and expiratory channel printed circuit boards (pcbs) were replaced and the issues were resolved.The device was returned to clinical use.Review of device's logs confirmed activation of the reported technical errors.During evaluation of provided device's logs, it was found that the device also generated technical error codes indicating turbine module communication error, power errors and o2 evacuation fan error.Battery extension pcb is a connector board.It connects battery back-plane to dc/dc & battery control.There are no active components on battery extension pcb.Expiratory channel pcb is part of subsystem breathing bre.The main functions are expiratory flow measurement and expiratory cassette handling.Expiratory flow measurement is performed by the flowmeter in the cassette.Expiratory channel pcb is connected to the cassette via expiratory channel connector pcb.The causes of the claimed issues in this customer product complaint have been determined.The issues were related to battery extension and expiratory channel pcbs.
Event or Problem Description
It was reported that the ventilator generated technical error codes indicating blower restart error.There was no patient harm.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: 25277391
• Report Number: 8010042-2026-0000692
• Device Sequence Number: 9686009
• 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): 05/26/2026

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: 05/26/2026
• 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