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

Model Number 10165977

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Limb Fracture (4518)

Event Date 11/10/2020

Event Type  Injury  

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 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
• Type of Device: 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: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 10919296
• MDR Text Key: 218675706
• Report Number: 3003202425-2020-55882
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869010304
• UDI-Public: 04056869010304
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K183548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10165977
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention