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

Model Number	8607300
Medical Device Problem Codes	Gas Output Problem (1266); Incorrect Interpretation of Signal (1543); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
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 alarmed ¿ventilator failure¿ on a patient during pressure control.Patient could be ventilated manually by anaesthetist inside mri scanner.No injury reported.
Additional Manufacturer Narrative
The analysis was performed based on the submitted information including the electronic log file of the device.The reported ventilator failure could be confirmed by means of the log.The entries indicate that on the event date, november 1st 2024, (registered under pr(b)(4) the membrane vacuum pressure that is required to keep the ventilator diaphragm in place was too low.Also, an entry was found informing that the membrane vacuum pressure exceeded the maximum value for automatic ventilation.The fabius has reacted to the detected situation as specified- automatic ventilation was stopped and a corresponding alarm was posted.In this case fresh gas delivery (incl.Agent) remains available and the patient can be ventilated using the manual breathing bag.Additonally, an entry was found indicating that a combination of a fresh gas deficit with an improperly opening auxiliary air intake valve has caused a ventilator failure.During downward movement of the piston, the device detected that a negative pressure has been built-up to a certain level which is an indication for a fresh gas deficit.Such fresh gas deficit can be caused by an unsuitable fresh gas setting and-or leakages in the patient circuit.The log entries do not allow for a more detailed analysis regarding the exact root cause.The fabius is designed to open an auxiliary air intake valve on top of the ventilator to compensate the fresh gas deficit with ambient air.According to the log, the compensation did not happen as expected indicating that the movement of the auxiliary air intake valve was restricted.The negative pressure further increased and the fabius finally reacted as specified by temporarily stopping the piston movement and generating a ventilator failure alarm.In such case ventilation will resume automatically once the pressure is within the accepted range.It is unknown why the device was put back into operation after the first event without any measures.The second event took place november 29th 2024, registered under pr(b)(4).The same two log entries of a too high and too low membrane vacuum pressure were found for this date.After the second event draeger was informed.A service technician went on site and was able to duplicate the issue.In consequence, the auxiliary air valve was replaced, the vacuum pump got calibrated and the ventilator lid + upper and lower diaphragm got replaced.The device was tested and was returned to use.On january 7th 2025 a service technician performed an ipml which did not pass.Entries have been found that the airway pressure (paw) has gone very negative, that the ventilator cylinder pressure dropped below -15 mbar and that the measured airway pressure is more than +10mbar above the pmax limit, adjusted by the user.Based on these findings the paw sensor and ventilator pressure sensor on the pcb have been replaced.Afterwards, the iplm has successfully passed.Additionally, the device underwent three long test runs in different ventilation modes without showing any deviation from specification.It can be concluded that at any time the device has reacted as specified by posting corresponding alarm to inform the user about the situation.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 alarmed ¿ventilator failure¿ on a patient during pressure control.Patient could be ventilated manually by anaesthetist inside mri scanner.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: 21109143
• Report Number: 9611500-2025-00018
• Device Sequence Number: 8760568
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)181016(93)8607300-45
• 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): 02/25/2025

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2018
• 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