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

Model Number	03780629
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a through investigation of the reported event.A supplemental report will be submitted upon completion of the investigation.Section h6 g07001: trolley for monitor.
Event or Problem Description
Siemens became aware of an incident that occurred while operating the siremobil compact l system.During an emergency patient procedure, the user observed smoke coming from the monitor trolley.The user immediately turned off and unplugged the unit.The patient was transferred to a different medical facility for further treatment.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the detailed investigation of the reported issue.The investigation was performed on expert discussions (considering complaint description, customer service reports, system history, and system log files).During procedure, customer observed smoke coming out from monitor trolley, the system was immediately shut down and unplugged to ensure safety.Due to the unavailability of an alternate system, the patient was transferred to another hospital to complete the procedure.No adverse health consequences were reported as a result of this event.During complaint investigation the system data was reviewed, the system was installed in the year 2004.System is already reached end of support (eos) since (b)(6) 2020, and the customer do not have any active maintenance service contract.During onsite service intervention, the customer service engineer (cse) observed that a capacitor of power unit (m14) was broken and generated the smoke.The age significantly suggests normal wear and tear for the components in the system and failure may take place with increased possibility.As the customer has not yet responded back to siemens regarding further steps to be taken on the system, no further service action is planned.Unfortunately, a more in-depth and verifiable analysis of the problem described in the complaint was not possible, because the affected part power unit (m14) was not returned.Therefore, the exact cause of the complaint could not be determined retrospectively.However, based on expert opinion and the absence of similar incidents, it is assumed that the power unit (m14) likely failed and caused the system malfunction.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.This complaint has been closed.

• 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: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 22411342
• Report Number: 3004977335-2025-00081
• Device Sequence Number: 8407362
• Product Code: OXO
• UDI-Device Identifier: 04056869008998
• UDI-Public: (01)04056869008998
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 07/21/2025

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: 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: 06/27/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/21/2025
• 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