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	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported in an ufr that the anesthesia workstation suddenly shut-down automatic ventilation during a surgical procedure.As per report, the users bridged patient support with a manual resuscitation bag and introduced another anesthesia device then.As per report, the event did not lead to health consequences for the patient.It was further mentioned that the initially used device was restarted whereby normal function could be restored.
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 so far.The contact person named in the ufr could not provide further information beyond the aspect that the device is back in use.Dräger derives the following: the device responds to various conditions with a shut-down of automatic ventilation to protect the patient from potentially hazardous output, and this is not limited to component malfunction.For example, if pressure is applied to the patient's chest in a moment when the ventilator is applying a ventilation hub, this may lead to fast rise in airway pressure upon which the device interrupts ventilation.Depending on the duration of the condition the device may post a vent fail alarm.The reported aspect that the device was functional again after a restart would speak for a non-persisting error condition which is rather unlikely to cause by component malfunction.Finally, the triggering condition for the shut-down of automatic ventilation remains unknown due to lack of information.The device is almost 10 years old; status of repairs and preventive maintenance is not known.The risk associated to a failure of automatic ventilation is under control - the device has an integrated breathing bag by means of which the user can perform manual ventilation including dosage of anesthetic gas.For the case the error condition may recur, it is recommended to the hospital to have the device checked by the local dräger sales & service organization.

• 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: 23874787
• Report Number: 9611500-2025-00712
• Device Sequence Number: 17570873
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)160426(93)8606000-83
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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: 12/16/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2016
• 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