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

Model Number	8606000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ufr was the only source of information - the local dräger s&s organization was not involved in any follow-up measures after occurrence of the event and was unable to obtain further information.A case-specific evaluation is not possible and thus, a reliable conclusion in regard to the exact root cause cannot be drawn.The description of event "stopped working" leaves room for interpretation.It cannot be differentiated if the unit ran completely out of energy supply and shut down or if automatic ventilation has stopped; other explanations may apply as well.For example, the effect of a large leakage in the patient circuit outside the device is sometimes misinterpreted by users as a device problem because the patient is not receiving enough breathing gas.The device is 3.5 years old, status of preventive maintenance and repairs is not known to dräger.Malfunctions of e.G.The ventilator or power losses will trigger corresponding alarms; all alarms, potential root causes and dedicated remedies are listed in the ifu.Further conclusions can't be made due to lack of information.The device design allows manual ventilation via the built-in breathing bag including gas dosage even in switch-off state.
Event or Problem Description
It was reported that the anesthesia workstation "suddenly stopped working" during a surgical procedure.As per report, the device was replaced, and no consequences for the patient have occurred.

• 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 21077051
• Report Number: 9611500-2025-00012
• Device Sequence Number: 6773847
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)200324(17)200919(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): Y
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

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): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2020
• 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
• Patient Sex: Unknown