MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM EMOTION 16; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 7734713

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Limb Fracture (4518)

Event Date 04/24/2021

Event Type  Injury  

Manufacturer Narrative

Siemens completed the technical investigation of the reported event as far as was possible.Requested logfiles associated to the event were not provided to siemens for review, there was a large time gap between the reported event date and the reporting of the event to siemens.Siemens support for this ct system model ended on december 31, 2019.Siemens checked the service history and evaluated the system itself.Siemens did not identify any technical issues during the review of the system service history or during the actual evaluation of the system.Further investigation and remedial action are not deemed necessary.

Event Description

It was reported to siemens on october 14, 2021, that the following event occurred during the use the somatom emotion ct 16 scanner on (b)(6) 2021: during a head scan (stroke diagnosis) the patient's arm was jammed into the ct gantry resulting in a fracture of the left humerus.The patient had to undergo surgery at another facility to treat the fracture.There was no device malfunction reported by the user.When asked if the patient was fixated with a belt, as recommended by the system manual for use, the reporter could not recall if fixation was used or not.Additional information regarding the event or the patient's current health status, was not provided to siemens.The reported event occurred in (b)(6).

• Brand Name: SOMATOM EMOTION 16
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 12686680
• MDR Text Key: 283968574
• Report Number: 3004977335-2021-01010
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K183548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7734713
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2021
• 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