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

Model Number	FLOW-I C40
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a difference between measured etco2 and paco2.There was no patient harm.Manufacture's reference #: (b)(4).
Event or Problem Description
Manufacture's reference #: (b)(4).
Additional Manufacturer Narrative
On-site investigation was performed by our field service engineer.The claimed issue was not reproduced during troubleshooting.According to received service report, no parts were replaced.The ventilator passed all functional and safety tests and was cleared for clinical use.The subject matter expert from manufacturer's site analyzed this case.The high co2 values for etco2 and paco2 indicates a mismatch in the ventilation/perfusion ratio in the lung.It usually happens when using too small tidal volumes, not compensating for dead space volume in heat and moisture exchanger (hme) leading to a larger shunt of pulmonary blood flow that does not take part in the alveolar gas exchange.The external dead space volume (volume of hme) added must be compensated by a corresponding increase in tidal volume.If instead the respiratory rate is increased, the gradient between etco2 and paco2 may be increased since a large part of the ventilation will only reach the physiological dead space compartment and thus not take part in the gas exchange.The root cause to the reported issue has not been determined.The correction of fields #h4 device manufacture date and #h8 usage of device was required.This is based on the internal evaluation.#h4 manufacture date: previous manufacture date: 09/08/2022.Corrected manufacture date: 08/31/2022.#h8 usage of device: previous usage of device: unknown.Corrected usage of device: reuse.

• 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: 16620947
• Report Number: 8010042-2023-00638
• Device Sequence Number: 7211497
• Product Code: BSZ
• UDI-Device Identifier: 07325710010631
• UDI-Public: (01)07325710010631(11)220831
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 03/27/2023

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 C40
• Device Catalogue Number: 6888540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown