MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM GO.TOP; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 11061640

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 10/18/2021

Event Type  Injury  

Manufacturer Narrative

The initial report is a siemens employee.The reporting facility contact name and phone number were not provided to siemens.Siemens has completed the technical investigation of the reported event.There was no device malfunction or design issue identified.The ct scanner was repaired.The root cause of the patient event was attributed to use error.The patient should have been fixated to the patient table per the system user manual recommendations.Remedial action is not deemed necessary.

Event Description

It was reported to siemens that during a ct examination of a patient with a plaster leg cast, the patient raised her casted leg and hit the ct scan window (plexi ring).The patient was not fixated properly, as recommended in the ct system user manual.As a result, the plexi ring was broken, and the patient's casted leg contacted the rotating gantry.Part of the plaster cast was removed by the rotating gantry and the patient sustained injury to her leg.The patient's wound was approximately 5 centimeters in length and required sutures to treat it.It was further reported to siemens that there was no permanent deterioration to the patient's health status due to this event.There is no allegation of system malfunction by the user.This report has been submitted with an abundance of caution.The reported event occurred in (b)(6).

• Brand Name: SOMATOM GO.TOP
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 12723478
• MDR Text Key: 284479400
• Report Number: 3004977335-2021-01406
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869151571
• UDI-Public: 04056869151571
• Combination Product (y/n): N
• PMA/PMN Number: K211373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11061640
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/18/2021
• 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
• Patient Age: 82 YR