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

Model Number	FLOW-I C30
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilation stopped during patient treatment.There was no patient harm.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The anesthesia system was investigated at the hospital by our field service engineer (fse).No technical errors were found in the logs.The system was tested and the system checkout passed.The anesthesia system was cleared for clinical use.A complete set of device logs was received for evaluation which concluded that a successful system checkout was performed in the morning on the event day.There are no recordings in the technical log during the case.The trend log has no recordings since the logs were saved more than 24 hours after the reported event the event log contains clinical alarms such as leakage, airway pressure: high, regulation pressure limited, respiratory rate: high, expiratory minute volume: low, airway pressure: high, regulation pressure limited and breathing circuit disconnected, which indicate difficulties with ventilating the patient.We have however not been able to determine the true cause of the generated alarms during patient treatment since no fault could be reproduced by the fse when investigating the system at the hospital.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: FLOW-I
• 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: 17478677
• Report Number: 8010042-2023-01512
• Device Sequence Number: 2711106
• Product Code: BSZ
• UDI-Device Identifier: 07325710010624
• UDI-Public: (01)07325710010624(11)230217
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 08/08/2023

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: FLOW-I C30
• Device Catalogue Number: 6677300
• 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: 07/20/2023
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown