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

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	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ufr was the only information for this case; the hospital did not involve the local dräger s&s organization into any follow-up measures.The contact person named in the ufr could not provide additional details.A case-specific evaluation is not possible.It cannot be determined what indeed is meant with "stopped working".A full shut-down of the device due to e.G.Loss of energy supply would be a completely different scenario than a shut-down of automatic ventilation.The supervisor function of the sw will force a shut-down of automatic ventilation as a response to various conditions to protect the patient from potentially hazardous output.Not all of these conditions are related to malfunction - also a fast rise in airway pressure caused by repositioning of the patient may be an imaginable scenario.The safety concept of the device allows manual ventilation via the built-in breathing bag including gas dosage also in switched-off state.Flow readings are not used for control purposes in gas dosage or ventilation - a flow sensor failure will thus not cause a shut-down of ventilation.The effects of a large leak in the patient circuit outside the device may also be misinterpreted as an output stop since no flow is noticeable at the patient opening; it may also explain the aspect of perceived flow sensor malfunctioning due to absence of flow readings from the screen.Finally, the available information does not allow a differentiation of what indeed has happened, and this report is filed in abundance of caution.It is recommended to the hospital to have the workstation checked by trained service personnel.
Event or Problem Description
Dräger received an ufr in which the following was stated: " during use, the device suddenly stopped functioning, with the flow sensor malfunctioning.It was immediately replaced with another anesthesia machine." it was mentioned that 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: 22505520
• Report Number: 9611500-2025-00383
• Device Sequence Number: 21148500
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)190416(93)8606000-87
• 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): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: 07/01/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown