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	05/20/2025
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.
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.
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 ventilator motor was returned to the dräger headquarter and inspected; the log file of the workstation was evaluated as well.It could be revealed that the on-site expertise was valid and that the repair measure was appropriate.The supervisor software detected speed fluctuations of the motor during the concerned procedure and forced a shut-down of automatic ventilation as designed, a corresponding vent fail alarm was posted.There are appropriate risk mitigation measures in place - the device must be operated under constant supervision of a trained user who will immediately become aware of the shut-down of automatic ventilation.The device design allows manual ventilation by means of the integrated breathing bag including gas dosage - even in switch-off state.The use of an external patient gas monitor is mandatory; the user will thus have a continuous overview of certain vital parameter.The safety concept of the ventilation shut-down can be explained as follows: the aforementioned speed fluctuations result in a deviation between measured and expected piston position.The piston hub defines the applied tidal volume and thus, to prevent from potentially hazardous output and/or from damages to the ventilator unit, the system is designed to shut down automatic ventilation.The phenomenon is typically related to wear and tear of the carbon brushes which usually occurs after the specified operation time of the motor has been reached.In this particular case, the error condition manifested after 5 years already; it was observed that the conductive pads of the carbon brushes were not properly pressed against the collector because the respective springs were burnt.This has been observed in isolated numbers in the past; the supplier has been informed and has conducted an investigation.The specification of the carbon brush holder has been narrowed thereupon.Dräger monitors the field failure rate of the ventilator motor continuously; the numbers are within expected range and thus accepted.The motor exchange has put back the workstation into fully operable state.
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.

• 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: 23081640
• Report Number: 9611500-2025-00528
• Device Sequence Number: 10064998
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)200427(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,Followup
• Report Date (Section B): 10/29/2025

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: 10/20/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2020
• 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.; NA.
• Patient Sex: Unknown