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

Model Number	8607300
Medical Device Problem Codes	Failure to Deliver (2338); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fabius mri rebooted 3 times during ventilation when the radiologist starting scanning the patient.The device was well behind the marked line on the floor and no alarms indicated that the device was too close to the magnet.The screen went black with the command text visible on the screen, ventilation was ceased and this reoccurred a further two times before scanning was ceased and the device was pulled out of the room.The anesthetist continued the case with the machine positioned outside of the mri room following a system test was indicated the machine was functional.No injury reported.
Additional Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.The unique device identifier (udi) of the affected product could not be determined due to the missing serial number of the device.We will request the serial number from the customer.If this attempt leads to an udi, it will be included in the follow-up report.
Additional Manufacturer Narrative
The device log file was requested but was not provided for investigation.Therefore, a case specific analysis was not possible and a root cause for the reported symptom could not be determined.A restart or shut down as reported is obvious for the user, since the device is intended to be used under constant supervision only.In any case the user can switch to manual ventilation as described in the instructions for use.Finally, due to insufficient information, no conclusion could be drawn about the cause of the reported interruption of ventilation.
Event or Problem Description
It was reported that the fabius mri rebooted 3 times during ventilation when the radiologist starting scanning the patient.The device was well behind the marked line on the floor and no alarms indicated that the device was too close to the magnet.The screen went black with the command text visible on the screen, ventilation was ceased and this reoccurred a further two times before scanning was ceased and the device was pulled out of the room.The anesthetist continued the case with the machine positioned outside of the mri room following a system test was indicated the machine was functional.No injury reported.

• Brand Name: FABIUS MRI
• 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: 21983400
• Report Number: 9611500-2025-00233
• Device Sequence Number: 8312963
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498
• Combination Product (Y/N): N
• PMA/510(K) Number: K072884
• 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): 06/30/2025

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: 8607300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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