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	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was reported by the hospital to the national authority only.The user facility did not involve the local draeger s&s organization into evaluation or repair of the device.Draeger tried to obtain further information or additional details about the event and follow-up actions - without success.The device was manufactured in october 2019 - its status of preventive maintenance and repairs is unknown to draeger.The lack of information does not allow a case-specific evaluation and no reliable conclusion in regard to the potential root cause.In fact, it can even not be confirmed that indeed a ventilator/ventilation failure has occurred.The manufacturer finally concludes - given that a malfunction of the device has occurred - the device is designed to post a corresponding alarm if automatic ventilation fails.There's a breathing bag integrated to ensure that patient support can be done by means of manual ventilation, but reportedly - according to the user facility report - this also failed during the event.An assessment which scenario may apply for this particular event is not possible due to missing relevant information.The event may have been the consequence of a component malfunction, an use error or an infrastructure issue or a combination of these factors.
Event or Problem Description
It was reported that during use on a patient, after anesthesia induction, both the manual and machine controlled modes of ventilation failed to function, preventing the anesthesia from proceeding as planned.The anesthesia device was replaced by a back-up machine - no injury or serious impairment of patient's state of health was 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 21227311
• Report Number: 9611500-2025-00026
• Device Sequence Number: 20722648
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)191022(17)200422(93)8606000-88
• Combination Product (Y/N): N
• 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): 01/24/2025

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: 01/13/2025
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown