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

Model Number	8607000
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a ventilator failure occurred during use.No injury reported.
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 a ventilator failure occurred during use.No injury reported.
Additional Manufacturer Narrative
Based on the logfile analysis, an entry (v044) was found indicating that during the case in question, the membrane vacuum pressure, that is required to keep the ventilator diaphragm in place, was too low.It could be concluded that the lower rolling membrane was causing a leakage and the following vent-fail.Consequently, the lower diaphragm was replaced during on-site checking in follow-up to the event.As a preventive measure, the ventilator assembly has been replaced as well.Dräger finally concludes that 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; no patient consequences have been reported.The replacement of the lower diaphragm has already solved the problem.After replacement, the device passed testing and was returned back to use with no further problems reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 23070799
• Report Number: 9611500-2025-00526
• Device Sequence Number: 11958673
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 8607000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 12/10/2025
• 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