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	12/09/2024
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 by the hospital in any follow-up measures.Dräger was unable to obtain further information - the contact person named in the ufr could not provide additional details.A case-specific evaluation is not possible, and a reliable conclusion in regard to the exact root cause for the reported observations cannot be drawn.In fact, it is even not clear that a device malfunction has occurred - there is no sudden occurring single-fault condition imaginable which would affect both automatic as well as manual ventilation and will later be removed by itself.A large leakage in the pneumatic circuit outside the device would be a more likely explanation - the user's attempts to re-establish ventilation may have eliminated the leakage unnoticedly.It would also be plausible that automatic ventilation had failed for unknown reason and that the users missed to switch the apl valve to the man/spont position in the first attempts to perform manual ventilation.Further conclusions can't be made; it is recommended to have the device checked by trained service personnel.
Event or Problem Description
It was reported that automatic ventilation failed during a surgical procedure.As per report, the users were at first unable to use the device in manual ventilation mode and were bridging patient support with an ambu bag.After several changes between automatic and manual ventilation, the procedure could reportedly be finished in manual 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 21077156
• Report Number: 9611500-2025-00013
• Device Sequence Number: 12858478
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)180920(17)190319(93)8606000-85
• 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: 09/20/2018
• 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