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

Model Number	8607300
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was just started.The results will be forwarded after conclusion.
Event or Problem Description
It was reported that the o2 centre sensor failed and a ventilator failure occured.No injury reported.
Additional Manufacturer Narrative
For the investigation the logfile was analysed.Both the described problems could be retraced.The logfile showed that the measured difference between the two o2 sensor cells was too high during ventilation.In this case no o2 values are displayed and the device alarms for o2 sensor fail! as it was reported for this case.On site the o2 sensor was calibrated and the issue was solved.In general, replacing the o2 sensor capsule and calibration is possible during ventilation.The fio2-monitoring of the device ensures that missing o2 readings are obvious; no false or misleading values will be displayed.Neither ventilation nor gas delivery will be affected since the readings are not used for control purpose.Thus, the reported and confirmed vent fail was neither caused nor in context with the o2 calibration issue.The vent fail was found to be caused by the membrane vacuum pressure exceeding the maximum value for automatic ventilation (entry v045) during the case in question.The vacuum pressure is needed to operate the valves that control the ventilation cycles and to keep the diaphragm of the ventilator in place to avoid wrinkling during piston movement.If significant deviations are detected - in this case a too high vacuum - the software forces a shutdown of automatic ventilation to prevent from serious mechanical damages to the ventilator unit.This is accompanied by a corresponding alarm; manual ventilation and the monitoring functionalities remain available.During on-site check in follow-up to the event, the service engineer replaced the vacuum pump and the performed test according to manufacturer's specification passed successfully.It can be concluded that the device responded as designed upon the detected deviation in vacuum pressure by initiating an emergency shutdown of automatic ventilation.It can be further concluded that also in regard to the found o2 calibration issue, which was independent from the vent fail, the device behaved according to its safety concept.Calibration of the o2 sensor is described in the ifu.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 o2 centre sensor failed and a ventilator failure occured.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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 23355719
• Report Number: 9611500-2025-00588
• Device Sequence Number: 9202251
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)210120(17)210615(93)8607300-48
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/05/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2021
• 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