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	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The anesthesia system was investigated at the hospital by our field service engineer (fse).The reported issue could not be reproduced and no parts needed to be replaced.The anesthesia system passed all performance and safety tests in accordance with factory specifications and was cleared for clinical use.A complete set of device logs were downloaded and sent for evaluation.The received logs confirm that there were issues with ventilating the patient on several occasions during the case.There is no data in the trend log due to the logs having been saved more than 24 hours after the event and there are no recordings of technical malfunctions in the technical log.Without having the trend log to evaluate ,we have not been able to confirm how much the flow, concentration and pressure actually deviated from set or expected values.The true cause of the reported event has not been determined.
Event or Problem Description
Manufacturer's reference number: (b)(4).It was reported that the anesthesia system did not cycle properly.There was no patient harm reported.
Additional Manufacturer Narrative
A correction of field # d1 brand name, # d4 version or model #, # d4 unique identifier (udi) # and h4 manufacturer date were required.D1 ¿ brand name - previous brand name: flow-i, corrected brand name: flow-i c40 anesthesia system d4 ¿ version or model # - previous.Version or model #: flow-i c40, corrected version or model #: 6888540.D4 ¿ unique identifier (udi) # - previous unique identifier (udi) #: missing, corrected unique identifier (udi) #: (b)(4).H4 ¿ manufacture date - previous manufacturing date: 01/31/2022, corrected manufacturing date: 01/10/2022.
Event or Problem Description
Manufacturer's reference number: (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: 17948284
• Report Number: 8010042-2023-02007
• Device Sequence Number: 20612832
• Product Code: BSZ
• UDI-Device Identifier: 07325710010631
• UDI-Public: (01)07325710010631(11)220110
• 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): 10/17/2023

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: 6888540
• Device Catalogue Number: 6677400
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown