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

Model Number	8607000
Medical Device Problem Codes	Device Reprocessing Problem (1091); Gas Output Problem (1266); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported date of event no device problem was found in the logfile.However, in the course of the investigation, it became apparent that on (b)(6) 2025 a ventilator failure occurred.The log file analysis indicates that for this date only a negative pressure exceeding -15mbar was measured inside the ventilator cylinder during downward movement of the piston which indicated a fresh gas deficit.Such fresh gas deficit can be caused by an unsuitable fresh gas setting and/ or leakages in the patient circuit.The device facilitates an auxiliary air intake valve that opens at -8mbar to take in ambient air for compensation of the fresh gas deficit.However, the negative pressure further increased to -15mbar and, the fabius finally reacted as specified by temporarily stopping the piston movement and generating a ventilator failure alarm.Based on experience a sticking auxiliary air intake valve may have caused that a fresh gas deficit could not be compensated by device countermeasures that would be initiated when the airway pressure becomes negative.A sticking auxiliary air intake valve can be the result of insufficient reprocessing.The dispatched fse could neither duplicate the error condition nor find any hints of a device malfunction.Dräger finally concludes that the device reacted as designed upon an error condition of unknown origin; the ventilator operation was temporarily stopped as long as the negative pressure was measured; a corresponding alarm is being posted for the duration the negative airway pressure is measured.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was found that during a case on (b)(6) 2025 the device went to a vent fail.No injury was 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: 21983396
• Report Number: 9611500-2025-00235
• Device Sequence Number: 8312960
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)240422(17)240813(93)8607000-79
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 05/08/2025

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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