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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case on (b)(6) 2025 the device went to a vent fail and there was no tidal volume or pressure readings.No injury was reported.
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 and thus the case was assessed reportable retrospectively.The log file analysis indicates that the piston movement of the ventilator was temporarily stopped during the concerned procedure due to a negative airway pressure measured.As the dispatched fse could neither duplicate the error condition nor find any hints of a device malfunction it can be assumed that the triggering condition was not device-related; a reasonable explanation would be the use of a bronchial suction system or patient activity.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.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.

• 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: 21889398
• Report Number: 9611500-2025-00207
• Device Sequence Number: 11651007
• 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): 04/23/2025

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: 04/17/2025
• Initial Report FDA Received Date: 04/23/2025
• 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