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

Model Number 10165977

Device Problems Unintended Movement (3026); Device Handling Problem (3265)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Injury (2348)

Event Date 08/18/2016

Event Type  Injury  

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.Clear warnings and guidance are provided in the operator manual regarding patient positioning, safety accessories provided and observation of the patient during all table movements.Considering this, no corrective action will be initiated.This event occurred in (b)(6).

Event Description

It was reported to siemens that a patient sustained an injury after examination on the somatom emotion 16 system.After completion of a thorax examination, the system operator began table movements in order to unload the patient.The patients arms were not secured by the provided safety belt and during table movements the patients arm fell to the tabletop.As a result, the patient suffered a fracture to the right humerus.The patient was evaluated and received medical treatment.

• Brand Name: SOMATOM EMOTION 16
• Type of Device: SYSTEM, XRAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.; 278 zhou zhou road; shanghai, 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.; 278 zhou zhou road; shanghai, 20131 8; CH 201318
• Manufacturer Contact: meredith adams ; 40 liberty blvd; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 5942585
• MDR Text Key: 54422259
• Report Number: 2240869-2016-05024
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2016

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
• Device Operator: Health Professional
• Device Model Number: 10165977
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2013
• 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
• Patient Age: 78 YR