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	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was inspected on-site by a dräger service engineer who could confirm the reported behavior and trace it back to a faulty motor of the ventilator.The entire motor assembly has been replaced, the device passed all consecutive tests and has been returned to use.Case evaluation made by the manufacturer confirms the validity of the on-site expertise - the supervisor function of the software has detected speed deviations during motor rotation and has forced a shut-down of automatic ventilation.As confirmed for the particular case, the shut-down is accompanied by a corresponding alarm, and manual ventilation via the built-in breathing bag including dosage of all necessary gases including anesthetics is further possible.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.Since the nature of the issue is known and the related failure rate is within accepted range, a physical evaluation of the failed motor was not considered necessary.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that automatic ventilation failed during use whereupon the users decided to replace the device.No health consequences for the patient were resulting from the event.

• 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: 24996496
• Report Number: 9611500-2026-00178
• Device Sequence Number: 9813693
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)191011(17)200309(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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: 8606000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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