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	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system failed the leakage test during system checkout.There was no patient involvement.Manufacturer's reference number: 886275.
Additional Manufacturer Narrative
It was reported that the equipment does not pass the automatic leakage test during system checkout, our company field service engineer investigated the anesthesia system at the hospital.The patient cassette cassette was found to be the cause of the leakage test failure.The received logs confirm the reported leakage test failure.The patient cassette was updated with a maintenance kit for the patient cassette which solved the reported issue.The anesthesia system was cleared for clinical use.Based on the fact that the reported leakage was solved by installing a maintenance kit for the patient cassette in the machine, it is likely that the leakage occurred due to normal wear and tear of the parts included in the maintenance kit for the patient cassette.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Event or Problem Description
Manufacturer's reference number: (b)(4).
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: 09/08/2022, corrected manufacturing date: 08/31/2022.

• 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: 17851510
• Report Number: 8010042-2023-01914
• Device Sequence Number: 3390353
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2023

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 01/09/2024; 06/06/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 01/09/2024; 06/18/2024
• 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