MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS GS PREMIUM; ANESTHESIA UNITS

Model Number	8607000
Medical Device Problem Codes	Decrease in Pressure (1490); Failure to Deliver (2338); Inaccurate Delivery (2339); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still on going.The results will be provided with a follow-up report.
Event or Problem Description
It was reported that man/spont was not working as bag won't fill.Log analysis revealed that a ventilator failure occurred.No injury reported.
Additional Manufacturer Narrative
The error log was analyzed for the reported date of event.The entries indicate that the membrane vacuum pressure that is required to keep the ventilator diaphragm in place was too low.The fabius has reacted to the detected situation as specified- automatic ventilation was stopped and a corresponding alarm was posted.In this case fresh gas delivery (incl.Agent) remains available and the patient can be ventilated using the manual breathing bag.In addition, an entry was found that the system leak test, performed before patient use, was not passed.The device was inspected by a service technician.The reported issue could not be reproduced.All tests were passed and no indication for a device malfunction was found.Based on the results of the log analysis and on-site inspection it can be assumed that most likely an external leakage in the breathing circuit has caused the reported symptom of a bag that cannot be filled and the failed leak test.The root cause for the low membrane pressure can be manifold (e.G.Leak inside the apl bypass valve, leak inside the pump).As during on site inspection no failure was found the exact cause could not be determined.The device was confirmed to be operating per manufacturer's specification and was handed over to the customer without further problems reported.Dräger finally concludes that the fabius behaved as specified upon the detected deviation by shutting down automatic ventilation and alerting the user by means of a corresponding alarm.
Event or Problem Description
It was reported that man/spont was not working as bag won't fill.Log analysis revealed that a ventilator failure occurred.No injury reported.

• Brand Name: FABIUS GS PREMIUM
• Common Device Name: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 22183301
• Report Number: 9611500-2025-00298
• Device Sequence Number: 12908633
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)180829(93)8607000-71
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 8607000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown