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

Model Number 11330001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 08/03/2021

Event Type  Injury  

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 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
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 12365476
• MDR Text Key: 268063177
• Report Number: 3004977335-2021-92171
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869231044
• UDI-Public: 04056869231044
• Combination Product (y/n): N
• PMA/PMN Number: K200524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11330001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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: 89 YR