MAUDE Adverse Event Report: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. SOMATOM PERSPECTIVE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10495568
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The root cause was determined as customer misuse.It was determined that the patient was positioned inside the scan filed during the checkup which is contrary to the instructions for use (print no.C2-068-g.620.11.02.02).The patient was exposed to unnecessary radiation for about 253.75 mgy.This is much higher than a standard ct examination (not more than 10mgy), but lower than the injurious exposure 500 mgy according to fda whitepaper.The system was evaluated by a siemens service engineer and is operating as specified.The checkup procedure executes a set of functions to ensure that the ct scanner is well conditioned and able to provide high quality images.According to the instructions for use, no patient shall be scanned and no radiation exposure to patient in checkup procedure.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom perspective ct system.A patient was on the table and in the system through check-up of the system.The customer requested assistance with provision of a dose report for the checkup / calibration routine generated to assist with a potential clinical incident surrounding unnecessary radiation exposure to a patient.

• Brand Name: SOMATOM PERSPECTIVE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai 20131 8; CH 201318
• Manufacturer Contact: meredith adams ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843231631
• MDR Report Key: 20437971
• Report Number: 3003202425-2024-00003
• Device Sequence Number: 18266941
• Product Code: JAK
• UDI-Device Identifier: 04056869010335
• UDI-Public: (01)04056869010335
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2024

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: 10495568
• Device Catalogue Number: 10495568
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/14/2024
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown