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

Model Number	FLOW-E
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia workstation generated alarm indicating an occlusion.There was no patient harm.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
Based on provided information, the claimed issue was resolved without replacement of any parts.The reported issue took place on (b)(6) 2023 around 16:00.The evaluation of received device's logs on provided date of event from 15:00 revealed occurrence some clinical alarms (e.G.Etco2: low, respiratory rate: low, expiratory minute volume: low, peep: low, leakage, expiratory minute volume: high, fico2: high).Moreover, the alarms for airway pressure: high and regulation pressure limited have been noticed in the logs.No technical errors and alarms for sample line occlusion were found.Unfortunately, the trend logs is not available.Therefore, evaluation of delivered volumes is not possible.The etco2 signal was confirmed but was low and seemed to come and go.There also appear to be at least 2 disconnections.When comparing the set apl pressure when manually ventilating a patient with the set pc above peep, the set apl is 26 cmh2o while the set pc above peep is 9-10 cmh2o.There are many external variables that affect the co2 measurements, including sampling line problems and tube kinking, but none of these are detectable from flow-e data.The root cause to the reported issue has not been determined.The correction of field #h8 usage of device was required.This is based on the internal evaluation.#h8 usage of device: previous usage of device: unknown; corrected usage of device: reuse.
Event or Problem Description
Manufacturer's ref.#: (b)(4).

• Brand Name: FLOW-E
• 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: 16589671
• Report Number: 8010042-2023-00605
• Device Sequence Number: 4948335
• Product Code: BSZ
• UDI-Device Identifier: 07325710010457
• UDI-Public: (01)07325710010457(11)211021
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

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-E
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown