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

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	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An on-site investigation of device and log file has confirmed the user's report of unexpected shut-down of automatic ventilation during use.According to the log entries, the supervisor function of the device detected a wrong motor position and forced a shutdown of automatic ventilation.The shut-down was accompanied by a corresponding alarm.The ventilator unit has been replaced; the device passed all consecutive tests and was returned to use.Dräger has received earlier complaints of the same nature in isolated numbers.Evaluation of these revealed that wear-and-tear related damages of the motor's carbon brushes had resulted in contact interrupts between the carbon brushes and the collector during motor operation; speed fluctuations will be the consequence.The 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 and to alert the user to this condition by means of a corresponding alarm when the speed fluctuations exceed a certain threshold.The device design ensures that manual ventilation with the built-in breathing bag including gas dosage will be further possible - this allows at least the bridging of patient support until a replacement device can be introduced.The particular event is considered an isolated case; the number of such premature failures is inconspicuous and accepted.
Event or Problem Description
It was reported that the device suddenly alarmed during a surgical procedure and shut down automatic ventilation.As per report, the device was replaced.The event did not lead to consequences for the patient.

• Brand Name: FABIUS TIRO
• Common Device Name: ANESTHESIA UNIT
• 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: 21176423
• Report Number: 9611500-2025-00035
• Device Sequence Number: 11827909
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)191014(93)8606000-88
• Combination Product (Y/N): N
• 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): 01/16/2025

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): Initial
• Initial Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2019
• 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
• Patient Sex: Unknown