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

Model Number	6887900
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fixing screw that holds the monitor in place came loose and the monitor fell off from the anesthesia system.This occurred during a routine inspection.There was no patient involvement.Manufacturer's reference #: (b)(4).
Event or Problem Description
Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation of the reported failure in this complaint has been completed.Our field service engineer (fse) found that the touchscreen on the monitor had been damaged, it was replaced with a new touchscreen, which resolved the issue.Following this, the anesthesia system was returned to the customer in good working condition.It is essential to apply the specified tightening torque (in newton meters) to the monitor mounting screws to ensure stability under load and continuous movement.Our conclusion, based on the available information, is that the corrective measures resolved the reported issue.However, the underlying cause of the loose screws could not be determined.
Event or Problem Description
Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The following corrections have been made based on the new information received from our field service engineer.Section d; d1 brand name: flow-e anesthesia system d4 version or model #: 6887900 d4 serial#: (b)(6) d4 unique identifier (udi) #: (b)(4) section h; h4 manufacture date: 2021-11-30.

• 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: 22469794
• Report Number: 8010042-2025-0001075
• Device Sequence Number: 17211524
• Product Code: BSZ
• UDI-Device Identifier: 07325710010457
• UDI-Public: (01)07325710010457(11)211130
• 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,Followup
• Report Date (Section B): 07/10/2025

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: 6887900
• Device Catalogue Number: 6888520
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 10/06/2025; 10/15/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 10/06/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown