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

Model Number 10430603

Device Problem Positioning Problem (3009)

Patient Problem Abrasion (1689)

Event Date 06/19/2023

Event Type  Injury  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.Based on the available information the root cause of the issue points to insufficient fixation of the patient.The patient should be fixed according to the instructions for use (print no.C2-030.620.15.03.02).Should the technical investigation identify a general design, systematic issue or any other reason, a supplemental report will be filed.

Event Description

It was reported to siemens that an adverse event occurred while operating the somatom definition flash ct system.On (b)(6) 2023, during a scan of an unconscious patient, the patient involuntarily kicked their leg and broke through the ct gantry plexi-ring (scan window).As a result, the patient suffered an injury to the knee which required stitches.We are unaware of any further impact to the state of health of the patient involved as the hospital in south korea did not provide further information.

• Brand Name: SOMATOM DEFINITION FLASH
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 ~or~; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 ~or~; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 17215891
• MDR Text Key: 318008692
• Report Number: 3004977335-2023-00051
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10430603
• Device Catalogue Number: 10430603
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male