MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG SIREMOBIL COMPACT L; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number	03780629
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.
Event or Problem Description
Siemens became aware of an event that occurred while operating the suremobil compact l system.During a surgery, dense black smoke was observed emanating from the machine, accompanied by a strong burning smell.The device was immediately removed from service.On november 11, 2025, siemens was informed that the smoke caused temporary discomfort to the people present.Detailed clarifications of this event are currently ongoing; therefore, the event is reported in doubt.We have no indications of any serious adverse effects on the health status of the involved persons.
Additional Manufacturer Narrative
The investigation was completed by our experts.During an on-site service intervention, a visual inspection of the concerned system did not reveal any defective parts, and the unit operated without any issues.However, the burning smell was still present, and it was determined that it originated from the power supply m14.The power supply m14 has been replaced, and the burning smell disappeared.After one week of monitoring, no further issues have been reported.The system siremobil compact l reached its end of support date on dec 31st.2020.The affected system including the replaced power supply has been delivered in december 2001.The system age significantly suggests normal wear and tear of its components, which increases the likelihood of failure.Siremobil compact l and its component had been verified to be in compliance with the safety requirements of iec60601-1, clause 13.The issue described in the complaint will not cause emission of flames, molten metal, poisonous or ignitable substances in hazardous quantities.The affected part was replaced as part of service activity, which resolved the problem.The spare parts consumption of the defective power supply was checked.Any accumulation of faults or even a possible general fault that would require corrective action of the installed base could not be determined by the investigation.

• Brand Name: SIREMOBIL COMPACT L
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 -or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 -or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 23658394
• Report Number: 3004977335-2025-00137
• Device Sequence Number: 17369403
• Product Code: OXO
• UDI-Device Identifier: 04056869008998
• UDI-Public: (01)04056869008998
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K963093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 03780629
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown