MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30 ANESTHESIA SYSTEM; GAS-MACHINE, ANESTHESIA

Model Number	6677300
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unique identifier (udi) # information is not available since the device was manufactured before the implementation of udi in manufacturing.
Event or Problem Description
It was reported that there was an increase in measured fico2 during surgery.There was no patient harm.Manufacturer's reference number: (b)(4).
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the reported failure in this complaint has been completed.No device log was available to confirm the increase in measured fico2 during surgery.The distributor calibrated the gas analyzer on the anesthesia system and there was no part replaced.The root cause of the reported issue has not been determined.The unique identifier (udi) # information is not available since the device was manufactured before 10/18/2015.¿ date of implementation of udi in manufacturing.

• Brand Name: FLOW-I C30 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: 20211038
• Report Number: 8010042-2024-01505
• Device Sequence Number: 7857955
• Product Code: BSZ
• UDI-Device Identifier: 07325710001363
• UDI-Public: (01)07325710001363(11)151120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/13/2024

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: 6677300
• Device Catalogue Number: 6677300
• 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: 08/16/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown