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

Model Number	6677200
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system stopped ventilating the patient.An alarm for high airway pressure was present in the log.There was no patient harm.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the reported failure in this complaint has been completed.Our field service engineer (fse) conducted an on-site evaluation.A system checkout (sco) was successfully completed, and the reported issue could not be reproduced.Log analysis revealed successful system checkouts both prior to and following the event, however, the trend log didn't cover the event date.Treatment was started in manual mode and after eight minutes, the system shut down and was restarted within one minute.Treatment resumed in manual mode, followed by a switch to volume control.Alarms for leakage, peep: low, and respiratory rate: high were activated.Multiple changes in ventilation modes were then performed.Treatment concluded after about one hour.The technical log has no recordings during this date which indicate the absence of technical malfunctions in the system.The exact root cause of the issue remains unclear and has not been determined.The presence of etco2 according to the logs indicates that ventilation was occurring.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: FLOW-I C20
• 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: 21856739
• Report Number: 8010042-2025-0000584
• Device Sequence Number: 20010881
• Product Code: BSZ
• UDI-Device Identifier: 07325710001363
• UDI-Public: (01)07325710001363(11)180418
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 04/15/2025

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: 6677200
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown