MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C20 ANESTHESIA SYSTEM; GAS-MACHINE, ANESTHESIA

Model Number	6888520
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system generated alarms for high airway pressure during patient treatment.There was no patient harm.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Our investigation of this complaint has been completed.The anesthesia system was investigated at the hospital by our field service engineer.The anesthesia system was tested in ventilation mode and several system checkouts were performed.The reported issues could not be reproduced.No parts needed to be replaced.After successful performance and safety tests, the device was returned to the customer and authorized for clinical use.The customer has not confirmed date of event.A complete set of device logs was received for evaluation.The log has no recordings for the given date of event.The evaluation of the logs are performed for the last case that was started.The logs show that a successful system checkout was performed prior to the event.Following the successful system checkout, a case was started.Almost immediately after case start in volume control ventilation, the system generated alarms such as: peep: low, airway pressure: high, respiratory rate: high, leakage and expiratory minute volume: low.These alarms were generated off and on during approximately ten minutes.The system was briefly switched to manual ventilation, before switching back to volume control.The session in volume control lasted about eight minutes during which no alarms were generated.A few minutes later, a session in prvc was started which lasted only for one minute.Then the user switched briefly to manual ventilation before switching back to prvc again.After one more switch between manual ventilation and prvc, alarms such as patient cassette disconnected, check breathing circuit, peep: low, respiratory rate: high, excessive leakage and expiratory minute volume: low, were generated before the case was ended.It is likely that these alarms came due to the patient having been disconnected.We have not been able to determine the true cause of the event.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: FLOW-I C20 ANESTHESIA SYSTEM
• Common Device Name: GAS-MACHINE, ANESTHESIA
• 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: 23345182
• Report Number: 8010042-2025-0001560
• Device Sequence Number: 21195282
• Product Code: BSZ
• UDI-Device Identifier: 07325710010617
• UDI-Public: (01)07325710010617(11)210325
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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: 6888520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown