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

Model Number	10165977
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Siemens completed the technical investigation of the reported event.The root cause of the event was identified as a user error.As emphasized on page 17 and 25 of the somatom emotion operator manual (doc id c2- 025.620.57.02.02): the patient must be positioned in such a way that he or she cannot collide with, or be injured by, the tabletop movements or the tilting movement of the gantry.Always fix and observe the patient during system movements.The system performed as specified and no system malfunction was detected.Further action is not warranted at this time.
Event or Problem Description
It was reported to siemens that during a ct scan using the reported somatom emotion system, the patient's leg was fractured when her knee collided with the gantry although she was stationary at the time.During the scan, the patient was unconscious, and her leg could not be properly stretched as she was positioned on the patient table.Her leg was bent toward her abdomen.During the procedure the patient's family was in the ct room and blocked the technician's line of sight, resulting in the technician not being able to observe the patient properly and the stop the table movement to prevent the collision.The patient was treated at the hospital for the leg fracture.The reported event occurred in the (b)(6).

• 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
• MDR Report Key: 10919296
• Report Number: 3003202425-2020-55882
• Device Sequence Number: 16766520
• Product Code: JAK
• UDI-Device Identifier: 04056869010304
• UDI-Public: 04056869010304
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K183548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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?: No
• Operator of Device: No Information
• Device Model Number: 10165977
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention