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	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dräger service engineer has evaluated the device and could confirm the reported ventilation shut-down.The triggering condition was a loss of the auxiliary vacuum pressure, caused by a cut in the actuation tube for the peep valve.After replacement of the tube the device was fully functional again.The issue can be reconstructed as follows: the auxiliary vacuum pressure is required to keep the ventilator diaphragm in place during piston operation and to actuate the valves that control the ventilation cycles.If the vacuum pressure gets out of range, the supervisor functionality of the software will force a shut-down of automatic ventilation to protect the patient from potentially hazardous output and to prevent from serious damages to the ventilator unit.A corresponding alarm will be posted.The device design allows to perform manual ventilation via the built-in breathing bag including gas dosage then.This ensures that patient support can at least be bridged until a replacement device is made available; the procedure may also be finished in manual ventilation.The control tube for the peep valve is routed outside the device; it may habe been damaged during use unnoticedly.
Event or Problem Description
It was reported that the device suddenly posted a vent fail alarm and shut down automatic ventilation.It was explicitly mentioned that the event did not lead to health consequences for the patient.

• Brand Name: FABIUS GS PREMIUM
• Common Device Name: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA

4518822868

• MDR Report Key: 22975224
• Report Number: 9611500-2025-00502
• Device Sequence Number: 18529005
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2017
• 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
• Patient Sex: Unknown