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

Model Number	6677200
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the on/off switch on the auxiliary o2 and suction unit was broken.There is no information stating whether a patient was connected to the anesthesia system or not.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.Our field service engineer investigated the system on site.The broken switch was already disassembled.The reported failure was confirmed.A new on/off switch was installed on the suction unit and the unit was successfully tested.The system was released for clinical use.There is no additional information such as in what way the switch broke or the circumstances during the event, if it was detected during functionality test or during treatment.The broken switch was discarded at the customer site.The suction unit intended use is to extract body fluids from the stomach and airways.The suction pressure is regulated by means of the on/off switch and the vacuum regulator.In case the on/off switch breaks in a way that it results in the inability to turn on the suction function, it can lead to stop of suction function.According to the user's manual, to ensure correct system functionality, a system checkout procedure must be performed once a day, or before connecting the first patient within a running 24 hour period.The system functionality procedure includes a check for adequate suction pressure in the suction unit.Our conclusion, based on the field service engineer investigation, is that the reported failure was caused by a broken suction unit on/off switch.

• 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: 25345744
• Report Number: 8010042-2026-0000704
• Device Sequence Number: 18688015
• Product Code: BSZ
• UDI-Device Identifier: 07325710001349
• UDI-Public: (01)07325710001349(11)181207
• 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
• Report Date (Section B): 06/01/2026

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown