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

Model Number	6887900
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suction device on the anesthesia system had a broken on/off switch.There was no patient harm reported.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Our investigation of this complaint has been completed.Our field service engineer investigated the system on site.The on/off switch on the suction unit was replaced.The replaced part was kept and discarded by the customer which prevented a further investigation of the part.There is no additional information such as in what way the switch broke or the circumstances during the event.The suction module is mechanical/pneumatic device and has no ability to generate logs.The suction unit is used 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.If the 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, prior to use, to ensure correct system functionality, optimal performance and patient safety, a system checkout procedure must be performed as follows: 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 is that the reported failure was caused by a broken on/off switch.The initially reported h4 manufacture date was incorrect.Therefore, the h4 manufacture date has been updated from 2021-11-11 to 2021-11-10.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: FLOW-E 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: 24127792
• Report Number: 8010042-2026-0000059
• Device Sequence Number: 10400598
• Product Code: BSZ
• UDI-Device Identifier: 07325710010457
• UDI-Public: (01)07325710010457(11)211110
• 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
• Report Date (Section B): 01/21/2026

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: 6887900
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown