MAUDE Adverse Event Report: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. SOMATOM EMOTION 16; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10165977
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, siemens concluded an investigation of the reported event.No issues were identified with the phs; all phs gaps are within specification.This ct system is operating according to specifications.This phs1a was designed based on iec 60601-1 and the phs gap fulfills the specification.Prior to delivery, this phs passed the final inspection, and warning label of hand injuries was attached.The operator manual, hc-c2-025.621.08, clearly indicates the following safety information and instruction: - immobilize the arms of the patient with the straps supplied to rule out collisions and injury to the hands under the tabletop.With obese patients, make sure that no collision occurs.(page 17&18 ).- observe the patient to avoid unintentional patient movement.(page 25).Several warning labels also attached on the phs.Based on the statement above, the system works as specified and it is not a product quality related issue.The patient was not correctly fixated on the phs, and the operator didn¿t observe the patient well during the table movement to avoid injury to the patient, it is customer¿s mis-operation.
Event or Problem Description
Siemens became aware of an incident that occurred while operating the somatom emotion ct-scanner.A mobility impaired patient (cerebral hemorrhage) injured her wrist during a ct scan.The operator did not use the retraining straps on the patient as stated in the instructions for use.The patient¿s hand dropped down when the phs (patient handling system) moved out from the gantry, resulting in her wrist bone to break.The patient was treated with a bandage and fixation at the medical facility.Current status of the patient is not known.Siemens requested additional information, however, the customer could not provide more specific information.

• Brand Name: SOMATOM EMOTION 16
• 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: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 22975895
• Report Number: 3003202425-2025-00004
• Device Sequence Number: 9370785
• Product Code: JAK
• UDI-Device Identifier: 04056869010304
• UDI-Public: (01)04056869010304
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10165977
• 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: 08/13/2025
• Initial Report FDA Received Date: 09/05/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown