MAUDE Adverse Event Report: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. SOMATOM EMOTION 6; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10165888
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom emotion 6 ct scanner.It was reported that the gantry rotation belt fell on the customer causing them to startle.No injury occurred and no medical treatment was needed.A belt and sensor replacement were completed, and the system is operating accordingly.Siemens has requested additional information to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.Additional information about the affected hardware for technical investigation has been requested.As this event is under investigation, the root cause has not yet been determined.A supplement report will be filed once new findings are available or the case has been fully analyzed.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be belt aging.Investigation discovered that the hospital staff had been hearing noises for about 4-8 weeks but did not take any action.Only when the noises became louder did the customer report them, and shortly afterwards the belt broke.The siemens service engineer replaced the broken belt, and the system was returned to clinical use.Broken belt investigation: the broken belt was returned for further investigation.It had been in use for over 17 years without replacement.After checking the belt, experts found the fracture surface is in the form of a brush, and delamination was found.The fracture tensile rope is in a brush-like shape and has layers.It is speculated that this is likely a case of cumulative aging fracture.Because the wedge teeth are intact and there are no obvious signs of the common microscopic cracks resulting from severe usage, another possibility could be: 1).Foreign object intrusion into the transmission based on the service engineers on-site feedback, no mention was made on foreign objects.Low possibility.2).Overload/overspeed.The rot control mechanism of the system is generally within 5%.No possibility.3).Inappropriate installation status.The belt was forcibly inserted into the pulley, creating a potential for rupture or the tension force was not used as required during installation.The system was regularly maintained by siemens.Low possibility.Maintenance: there is one gantry belt related inspection in full maintenance (every 12 months) --print no.Ct02-025.831.02.32.02: ¿3.23 gantry: checking the rotation drive belt and belt tension¿.The service engineer performed the belt inspection in the last maintenance activity and feedback was provided that the belt was still in good condition at that time.The hospital staff informed the siemens service engineer that they had been hearing noises for about 4-8 weeks but did not take any action.According to emotion instructions for use (print no.Hc-c2-025.621.08.01.02), customer should shut down the system and notify the siemens customer service if system malfunctions are detected.Based on the investigation, there is no design or systematic defect recognized.This problem was caused by belt aging.

• Brand Name: SOMATOM EMOTION 6
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai 20131 8; CH 201318
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 23389329
• Report Number: 3003202425-2025-00007
• Device Sequence Number: 18628296
• Product Code: JAK
• UDI-Device Identifier: 04056869010298
• UDI-Public: (01)04056869010298
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: 10165888
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 01/30/2026
• 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 Age: 63 YR
• Patient Sex: Male