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

Model Number 10742326

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 02/13/2024

Event Type  Injury  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event to identify the root cause of the issue.A supplemental report will be provided upon investigation completion.

Event Description

It was reported to siemens that an adverse event occurred while operating the somatom force ct system.On (b)(6) 2024, the customer reported a loud noise and observed that the ct gantry shifted it¿s original position.As a result, a patient was injured.Further information regarding the patient's health status and the extent of injury is not known at this time.Siemens has requested additional information to conduct an investigation of the reported event.Therefore, this report is submitted with an abundance of caution.

• Brand Name: SOMATOM FORCE
• 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: 18766667
• MDR Text Key: 336102829
• Report Number: 3004977335-2024-00022
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K230421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10742326
• Device Catalogue Number: 10742326
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other