MAUDE Adverse Event Report: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. SOMATOM EMOTION 16 (2007); SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 10165977

Device Problem Use of Device Problem (1670)

Patient Problem Bruise/Contusion (1754)

Event Date 05/18/2023

Event Type  Injury  

Event Description

It was reported to siemens healthineers that after the patient was examined with the somatom emotion 16 system, the patient hurriedly got off the system patient table when the table was still being moved downwards resulting in a fall.The patient reportedly has an unspecified mental disorder and in was in the company of family during the examination.The patient was not fixated with straps to the patient table (as indicated in the system instructions for use) during the examination.The patient¿s fall resulted bruising of the skin on the patient¿s forehead which was treated by a nurse at the facility.The reported injury was not severe.However, in a worst-case scenario, the lack of patient fixation during an examination could results in a severe injury if the issue were to recur.

Manufacturer Narrative

E1: a facility contact name was not provided.The reporting facility telephone number is (b)(4).H3, h6: the system instructions for use clearly indicate the following information and instruction along with additional cautions highlighted in the manual: if necessary, immobilize the patient with one or more restraint straps, such that the patient is centered on the table with the extremities secured.Take special care with those patients.Always fix and observe the patient during measurement.Always observe the patient during system movements.Based on the information above, this issue was due to the patient (with an unspecified mental disorder) not being correctly affixed on the system patient table and the lack of patient observation during table movement.This is not a product quality-related issue, and the system works as specified.The root cause is attributed to user error.

• Brand Name: SOMATOM EMOTION 16 (2007)
• 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: anastasia sokolova ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234197
• MDR Report Key: 17263301
• MDR Text Key: 318443830
• Report Number: 3003202425-2023-00003
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K050297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10165977
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other