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

Model Number	8606000
Medical Device Problem Codes	Degraded (1153); Failure to Deliver (2338); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still on going.The results will be provided with a follow-up report.
Event or Problem Description
It was reported that the device restarted during induction of anesthesia and mask ventilation.No injury reported.
Additional Manufacturer Narrative
Based on the log analysis it could be comprehended that the device repeatedly was switched on and off on the reported date of event.During on site inspection the battery and mains cable have been checked without identifying any deviation.Power supply and main board were replaced as a precautionary measure.Afterwards, the symptom of the device restarting was still present.As root cause a contact failure in the main switch was assessed and in consequence the main switch was replaced.No further problems have been reported to us since then.The main switch was requested for investigation but was not received.The instructions for use include a warning that the system has to be operated under the constant supervision and control of a qualified operator.So, an intermittently turning on/ off of the device due to a faulty main swich is directly apparent to the user.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.
Event or Problem Description
It was reported that the device restarted during induction of anesthesia and mask ventilation.No injury reported.

• 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: 22539808
• Report Number: 9611500-2025-00393
• Device Sequence Number: 20840169
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)210602(93)8606000-91
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2011
• 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.; NA.
• Patient Sex: Unknown