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); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that co2 increased when using fabius tiro on a patient.No injury reported.
Additional Manufacturer Narrative
Based on the log analysis the reported symptom of an increased co2 could not be comprehended.For the reported date of event the log entries indicate that the vacuum pressure that is required to keep the ventilator diaphragm in place was too low.The fabius reacted as specified for this situation- stopped the automatic ventilation and posted a corresponding alarm.In this case fresh gas delivery (incl.Agent) remains available and the patient can be ventilated using the manual breathing bag.The device was checked on-site by a draeger service technician.An issue with the cosy (compact breathing system) was identified.As the log entries also indicate leakages it can be assumed that these were also caused by the cosy.It was not possible during on-site inspection to find which component of the cosy has caused the issue.The cosy was requested for investigation but unfortunately was not received so that a detailed root cause analysis was not possible.But it can be concluded that most likely the cosy has caused the reported symptom of an increased co2 and the identified stop of ventilation during use.The fabius behaved as specified upon the detected deviations and alarmed accordingly to alert 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.The results of the investigation showed that the case was subsequently assessed as reportable.

• 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: 23766482
• Report Number: 9611500-2025-00679
• Device Sequence Number: 21254545
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)191122(93)8606000-88
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 12/10/2025

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2019
• 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
• Patient Sex: Unknown