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	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia workstation had a leakage.Evaluation of logs revealed that it generated a technical error code indicating adjustable pressure limit exceeded and an alarm indicating high continuous pressure.There was no patient harm.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
On-site investigation was performed by our field service engineer.The claimed issue was not reproduced during troubleshooting and no parts were replaced.However, the water trap was replaced by the customer before technician's inspection.The received device's logs has been evaluated.The successful system checkout was performed before case started.The mode has been changed to prvc and device generated alarms for leakage a few seconds later.More clinical alarms are visible in the logs related to leakage situation, e.G.: expiratory minute volume: low, etco2: low, alarm: apnea > 120 s.Moreover, alarms for continuous high pressure and technical error indicating exceeded adjustable pressure limit (apl) pressure have been confirmed.The root cause of the reported alarms has not been determined, as it remains unknown what was the source of the leak.
Event or Problem Description
Manufacturer's ref.#: (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: 17057910
• Report Number: 8010042-2023-01058
• Device Sequence Number: 6871811
• Product Code: BSZ
• UDI-Device Identifier: 07325710010624
• UDI-Public: (01)07325710010624(11)220223
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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: 6888530
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown