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

Model Number	8606000
Medical Device Problem Codes	Degraded (1153); Failure to Deliver (2338); No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia workstation suddenly posted an alarm during use and shut down automatic ventilation.The event did not lead to consequences for the patient; ventilation support was bridged in manual ventilation mode via the built-in breathing bag first until a replacement device could be introduced.
Additional Manufacturer Narrative
A dräger service engineer has inspected the device on-site, could confirm the reported behavior and trace it back to an issue with the ventilator motor.The motor has been replaced, the workstation passed all consecutive tests and was returned to use.The exact failure mechanism is under further investigation at the manufacturer.
Event or Problem Description
It was reported that the anesthesia workstation suddenly posted an alarm during use and shut down automatic ventilation.The event did not lead to consequences for the patient; ventilation support was bridged in manual ventilation mode via the built-in breathing bag first until a replacement device could be introduced.
Additional Manufacturer Narrative
A dräger service engineer has inspected the device on-site, could confirm the reported behavior and trace it back to an issue with the ventilator motor.The motor has been replaced, the workstation passed all consecutive tests and was returned to use.The replaced motor was returned to the manufacturer for evaluation but was damaged during transport, unfortunately.In particular, the so-called encoder disc which is part of the position detection system was seriously bent which made it impossible to check the motor in the dedicated test stand in the manufacturer's lab.It was confirmed with the service engineer that the damage was neither present before the exchange nor caused by the necessary worksteps.Due to the aspect that the motor could not be tested, it can only be concluded from the log file entries that the supervisor software detected a deviation between the measured and the expected motor position.The safety concept can be explained as follows: the ventilator motor is a step motor that drives a piston i.E.The number of rotations and the end position defines the piston hub; the piston hub is an equivalent to the tidal volume applied to the patient.To protect the patient from potentially hazardous output and/or from serious damages to the ventilator unit, the device is designed to shut down automatic ventilation when the divergence between expected and measured motor position exceeds a certain limit.The user will be alerted to the shutdown by means of a corresponding alarm, and manual ventilation with the built-in breathing bag including gas dosage will further be possible.Finally, even though the exact circumstances that led to the divergent motor position cannot be determined, it can be concluded that the system response was adequate as per definitions in the safety concept.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 TIRO
• 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: 23081641
• Report Number: 9611500-2025-00529
• Device Sequence Number: 21348335
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)191125(93)8606000-88
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: 8606000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2019
• 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