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

Model Number	6888520
Medical Device Problem Codes	Increase in Pressure (1491); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the flow sensors were not detecting pressures.There was no patient harm.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.Our field service engineer investigated the system on-site.No fault was found, and no parts were replaced.The system has been put into clinical use and no further issues has been reported.The system device logs were saved and sent for evaluation.The hospital staff were unable to give time and date.The evaluation of the device logs shows that in the last treatment period in the logs it seemed there was some issues during the first 35 minutes of that treatment.It is assumed that this is the treatment period the customer was reporting on.The treatment was ongoing for 2 hours and 35 minutes.The log shows that a successful system checkout was performed prior to the treatment start and after the event.The treatment was started in automatic ventilation, and two minutes after start, alarms for airway pressure high and regulation pressure limited were generated.The user decreased the set tidal volume, and the alarms ceased for 13 minutes, then the alarms were generated again.The alarms for regulation pressure limited and airway pressure high were then sporadically generated for 20 minutes, and after that, the treatment continued without alarms until the system was set to standby.The technical log has no entries, which indicate the absence of technical malfunctions in the system at the time of the event.The airway pressure high alarm is generated when the upper pressure limit is reached whereby the inspiration phase is terminated and goes over to expiration phase.The regulation pressure limited alarm is generated when the set volume is not attained due to the imposed restriction of the set upper pressure limit.Our conclusion, based on the investigation by our field service engineer and the evaluation of the logs, is that there is no indication of a system malfunction at the time of the event.The root cause of the reported event has not been conclusively determined.
Event or Problem Description
Manufacturer's reference #: (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: 23434093
• Report Number: 8010042-2025-0001602
• Device Sequence Number: 8672089
• Product Code: BSZ
• UDI-Device Identifier: 07325710010617
• UDI-Public: (01)07325710010617(11)240809
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/31/2025

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
• Device Catalogue 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: 10/09/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown