MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C20; GAS-MACHINE, ANESTHESIA

Model Number	6677200
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilation stopped while the anesthesia system was in use for treatment.There was no patient harm.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.The system was investigated by our field service engineer and the patient cassette and co2 absorber was replaced.No further issues have been reported with the system after this.The patient cassette and co2 absorber were retained by the customer.The evaluation of the received logs shows that the last system checkout was performed the day before the event, and it was successful.The log shows that three treatment periods were performed after the successful system checkout and before the actual treatment in which the reported failure occurred was started.No new system checkout or leakage tests were performed in between the treatment periods.The actual treatment period was ongoing for about four and a half hours.Alarms for leakage were generated during the entire treatment.During the first hour, a few alarms for peep low were also generated indicating that there may have been a real leakage.During the rest of the treatment, only alarms for leakage were generated indicating that there may have been a flow measuring error.The technical log for this date shows no entries, confirming that there were no technical malfunctions in the system.After the event, the patient cassette was replaced, before the system checkout was performed.The system checkout performed with the new patient cassette was successful.The patient cassette used at the time of the event has not been tested.The patient cassette is the main interface for distributing gas to and from the patient and the expiratory flow measurement is performed by the patient cassette.Our conclusion, based on the on-site investigation and log evaluation, is that the patient cassette was the cause of the reported event.
Event or Problem Description
Manufacturer's reference #: (b)(4).

• Brand Name: FLOW-I C20
• 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: 22952557
• Report Number: 8010042-2025-0001357
• Device Sequence Number: 18608866
• Product Code: BSZ
• UDI-Device Identifier: 07325710001349
• UDI-Public: (01)07325710001349(11)170222
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 09/03/2025

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: 6677200
• Device Catalogue Number: 6677200
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown