MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C40 ANESTHESIA SYSTEM; GAS-MACHINE, ANESTHESIA

Model Number	6888540
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system switched from automatic ventilation to manual ventilation without user interaction.There was no patient harm.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.The system was investigated by our field service engineer.The adjustable pressure limit (apl) control assemble was found defective and was replaced.It was disposed off at the customer site.The device logs were received for evaluation.Additional information received from the user facility stated that the ventilation mode change was from automatic to manual ventilation and then back to automatic ventilation again.The evaluation of the logs shows that system checkouts performed prior to and after the event were successful.The logs show that from start of treatment until end of treatment, about two hours, there were in total 13 changes, from automatic ventilation to manual ventilation and then back to automatic ventilation.After all these changes, the time in manual ventilation mode lasted only one to three seconds which indicate that these changes were spontaneously performed by the system.Our conclusion, based on the field service engineer investigation and log evaluation, is that the reported failure was due to a broken apl control assembly.The true cause to why the apl control assembly failed has not been established.
Event or Problem Description
Manufacturer's reference #: (b)(4).

• Brand Name: FLOW-I C40 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: 20394707
• Report Number: 8010042-2024-0001636
• Device Sequence Number: 8065994
• Product Code: BSZ
• UDI-Device Identifier: 07325710010631
• UDI-Public: (01)07325710010631(11)191008
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/08/2024

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: 6888540
• Device Catalogue Number: 6888540
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown