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

Model Number	11061640
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 12723478
• Report Number: 3004977335-2021-01406
• Device Sequence Number: 4282189
• Product Code: JAK
• UDI-Device Identifier: 04056869151571
• UDI-Public: 04056869151571
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K211373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2021

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
• Operator of Device: Health Professional
• Device Model Number: 11061640
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR