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

Model Number	11330001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens interviewed the facility contact regarding the incident and evaluated the event.Siemens did not perform a technical investigation and/or remedial action in response to the reported event since there was no allegation of device malfunction.The root cause of the reported issue was that the patient's arms were not fixated during the procedure because reportedly the patient was following the user's instructions.The injury occurred at the end of the end of the procedure, when apparently, she stopped following the user's instructions.
Event or Problem Description
It was reported to siemens that a moderate patient injury occurred at the end of the ct examination.During patient unloading from the scanner after the completion the examination, the patient's finger got caught in the "pinch zone" of the patient table, and an avulsion injury to the skin of the patient's fifth distal digit resulted.The patient was responding to commands from the facility staff up until the time of the incident.There was no report of a device malfunction.The patient's wound was cleaned and bandaged at the facility.Additional treatment included conservative management of the wound and observance for signs of infection for a week.The patient continues with weekly appointments at the orthopedic office.Additional negative health consequences to the patient were not reported to siemens.This report has been filed with an abundance of caution.

• Brand Name: SOMATOM X.CITE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 12365476
• Report Number: 3004977335-2021-92171
• Device Sequence Number: 3887594
• Product Code: JAK
• UDI-Device Identifier: 04056869231044
• UDI-Public: 04056869231044
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K200524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: 11330001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 89 YR