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

Model Number	8607000
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that due to a disconnected pressure hose on the back of the machine a ventilator failure occurred.No injury reported.
Additional Manufacturer Narrative
It was reported that the ventilator failure was caused by a disconnected pressure hose.It can be assumed that the silicone hose on the interface panel on the back of the device normally connected with the cosy got disconnected e.G.By moving the device or the cosy.It is also possible that someone got caught on the hose during handling and pulled it off the nozzle.The reported ventilator failure can be explained by disconnection of this pressure hose as the required pressure for ventilation in this case is no longer build up.The device reacted to the situation as specified by posting a corresponding "vent fail" alarm.The user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.Finally, it can be concluded that the reported issue was not caused by a device malfunction but by a handling issue which has led to disconnection of the pressure hose.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.

• 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: 24686270
• Report Number: 9611500-2026-00126
• Device Sequence Number: 9652930
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)170227(17)170722(93)8607000-69
• 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
• Report Date (Section B): 03/25/2026

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: 8607000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown