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

Model Number	6887900
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an increase in measured fico2 and etco2 during surgery.There was no patient harm.Manufacturer's reference number: (b)(4).
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the reported failure in this complaint has been completed.A complete set of device logs was received, however the trends logs was not covering the reported event.An evaluation of the device logs shows that no leakage test was performed before the treatment was started.A successful system checkout had been performed before a prior treatment was performed.The technical log has no recordings during this date, which indicate the absence of technical malfunctions in the system.The treatment was started in prvc ventilation mode and then changed to volume control started.After 15 minutes, the ventilation mode was switched to pressure control, at which point high fico2 alarms were repeatedly triggered, accompanied by high etco2.These alarms persisted for about one hour, until the upper alarm limit settings for fico2 and etco2 were increased and some adjustments to the ventilation settings were performed.After this the treatment continued for 2.5 hours, without any more alarms for high fico2 or etco2, until the system was set to standby.The log also shows that the co2 absorber was bypassed at 09:36 and remained bypassed for the duration of the case.The fresh gas flow was set to a higher flow than the minute volume, no re-breathing.Our conclusion, based on the evaluation of the received device logs, is that there is no indication a malfunction of the anesthesia system.The root cause of the event has not been determined.

• Brand Name: FLOW-E 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: 20547028
• Report Number: 8010042-2024-0001768
• Device Sequence Number: 7988722
• Product Code: BSZ
• UDI-Device Identifier: 07325710010457
• UDI-Public: (01)07325710010457(11)211111
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: 6887900
• Device Catalogue Number: 6887900
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown