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); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2025
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 further information.Dräger derives the following: the supervisor function of the software responds to various conditions with a shut-down of automatic ventilation to protect the patient from potentially hazardous output, and not all of these conditions are related to component malfunctions.For example, a fast transient rise in air pressure may lead to abortion of automatic ventilation.Such situation can occur when pressure is being applied to the patient's chest in a moment when the piston ventilator attempts to apply a breathing hub.It was reported that automatic ventilation stopped after a repositioning of the patient - it cannot be fully excluded that a malfunction has suddenly occurred in this moment but it is considered rather unlikely; a causal connection to the repositioning would be more plausible.Drawing a reliable conclusion is not possible for dräger without having the possibility to examine the device.Although the exact nature of the triggering condition remains unknown, a safety shutdown of automatic ventilation was most likely an adequate device response in this situation; the user was alerted to this condition by means of a corresponding alarm.The device design allows patient support in manual ventilation via the built-in breathing bag then.Finally, it is impossible to draw a reliable conclusion in regard to the root cause just from the written description.It is thus recommended to have the device checked by trained service personnel.
Event or Problem Description
Dräger received an ufr in which it was stated that the anesthesia workstation passed the pre-use check without deviation and that the initial part of the surgery went uneventful but that automatic ventilation did not work anymore after repositioning the patient.Patient support was reportedly bridged with an ambu bag until a replacement device was made available.It was explicitly stated that 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
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA

4518822868

• MDR Report Key: 22961154
• Report Number: 9611500-2025-00497
• Device Sequence Number: 13140469
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)171204(17)180330(93)8606000-85
• 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): 09/04/2025

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: 08/23/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2017
• 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