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

Model Number	8606000
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.Results will be provided with a separate follow-up report.
Event or Problem Description
It was reported that the device posted a ventilator fail alarm during use.There was no injury reported.
Additional Manufacturer Narrative
For the investigation the logfile was analysed.On the date of event it was found that the device detected an issue with the vacuum pressure immediately after turning the device on.This vacuum pressure is needed to operate the valves that control the ventilation cycles and to keep the diaphragm of the ventilator in place to avoid wrinkling during piston movement.If significant deviations are detected - in this case a too high vacuum - the software forces a shutdown of automatic ventilation to prevent from serious mechanical damages to the ventilator unit.This is accompanied by a corresponding alarm; manual ventilation and the monitoring functionalities remain available.During on-site checking in follow-up to the event, the vacuum pump was replaced.Afterwards, the device was checked and all tests according to manufacturer's specifications were passed.The device was then returned back to use without further problems described.The fabius detected a deviation and reacted according to specification immediately after turing the device on.This is why it was concluded that no patient was involved.The case has been re-assessed to be not reportable.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is monitored in the responsible pqb, in case it is decided that measures are necessary, this is derived from the pqb.
Event or Problem Description
It was reported that the device posted a ventilator fail alarm during use.There was no injury reported.

• 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: 23591774
• Report Number: 9611500-2025-00634
• Device Sequence Number: 13306740
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)180827(93)8606000-85
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2018
• 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