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	12/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia workstation stopped working.There was no patient harm reported.Manufacturer´s ref #: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.The anesthesia system was tested by the hospital personnel.A complete set of device logs was saved and sent for evaluation.The logs show some alarms for airway pressure high, peep high and regulation pressure limited, which may indicate an expiratory resistance.There is no indication of a technical failure in the system, no technical error, and the system checkout prior to and after the case were successful.According to additional information, the machine did not ventilate during the first seconds after the patient was intubated.Later, it worked fine, and the user was able to finish the case with the same machine without any problems.No further issues have been reported.The root cause has not been established by this investigation as the reported issue could not be reproduced.The correction of fields d1 brand name and d4 version or model # were required.This is based on the internal evaluation.Previous brand name: flow-i, corrected brand name: flow-i c40 previous version or model #: flow-i c20, corrected version or model #: 6677400.
Event or Problem Description
Manufacturer's ref: #(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: 18524183
• Report Number: 8010042-2024-00109
• Device Sequence Number: 7875806
• Product Code: BSZ
• UDI-Device Identifier: 07325710001318
• UDI-Public: (01)07325710001318(11)190423
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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: 6677400
• 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: 01/04/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown