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

Model Number	6882000
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our field service engineer (fse) has investigated the reported ventilator on-site.Reported issue was not reproduced during on-site visit and no parts were replaced to solve the issue.The reported issue was confirmed in provided device's logs.Evaluation found several alarms for high pressure and low delivered volume.The alarms indicate the efforts of the ventilator to deliver the set tidal volume and that the expiratory resistance had increased at the time for the event.According to the test log, the ventilator passed the pre-use check prior ventilation was started and the technical log does not contain any technical error codes to indicate that there was a ventilator malfunction at the time of the event.An increase in airway pressure can occur due to a blockage in the respiratory system.No information concerning patient breathing circuit or filter was provided.Our conclusion, based on the log evaluation, is that there was no ventilator malfunction.The ventilator detected and generated alarms for the high pressure situation.The cause of the issue has not been determined.
Event or Problem Description
The ventilator generated alarms indicating insufficient ventilation.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: 25647307
• Report Number: 8010042-2026-0000882
• Device Sequence Number: 5902766
• Product Code: CBK
• UDI-Device Identifier: 07325710003114
• UDI-Public: (01)07325710003114(11)200921
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2026

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: 06/16/2026
• Initial Report FDA Received Date: 06/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown