MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C40; GAS-MACHINE, ANESTHESIA

Model Number	6677400
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system had an error.There as no patient harm.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The field service engineer investigated the anesthesia system at the hospital.No faults were reproduced.The anesthesia system was cleared for clinical use.The device logs show that technical errors regarding the user interface (screen), the gas analyzer and the vaporizer had been generated.There was also a leakage issue during system checkout.Although the issues can be confirmed in the logs, we have not been able to determine any true cause of the issues.
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.D4 ¿ version or model # - previous version or model #: flow-i c40, corrected version or model #: 6677400.D4 ¿ unique identifier (udi) # - previous unique identifier (udi) #: missing, corrected unique identifier (udi) #:(b)(4).H4 ¿ manufacture date - previous manufacturing date: 12/23/2016, corrected manufacturing date: 12/14/2016.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: FLOW-I C40
• 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: 18073008
• Report Number: 8010042-2023-02150
• Device Sequence Number: 7585488
• Product Code: BSZ
• UDI-Device Identifier: 07325710001318
• UDI-Public: (01)07325710001318(11)161214
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 11/06/2023

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: 6677400
• Device Catalogue Number: 6677400
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 06/10/2024; 06/06/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 06/10/2024; 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose