MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- CT SOMATOM SCOPE POWER (DE); SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10046799
Medical Device Problem Codes	Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom scope power ct system.During system calibration without any patient involvement, the gantry rotation belt broke apart.As a result, it pushed the plexi-ring out of its holder and the belt came out of the gantry.There is no report of impact to the state of health of any patient or user involved, however, it cannot be excluded that this situation could have led to any injuries if a patient would have been on the table.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A siemens service engineer has repaired the ct scanner and returned the broken parts for investigation.A supplemental report will be filed upon completion of the material investigation.
Additional Manufacturer Narrative
Siemens healthineers conducted a thorough investigation of the reported event.The technical investigation of the belt showed many small cracks on the ribs of the belt.These are signs of ageing and are due to thermo-oxidative processes caused by the influence of temperature and oxygen.A change in the material structure due to ageing processes is usually associated with a negative change in the mechanical properties.This probably also led to the fracture in the present case.The belt became torn due to natural material aging.Currently the belt is checked during regular maintenance and if aging is detected, the belt must be replaced.To enable service personnel for better detection of aging signs in future, the service instruction will be improved including more pictures of samples.: corrected data h7: repair and inspection were checked in the initial report submitted on may 21, 2023.These selections were checked in error.There was no remedial action initiated for the complaint event.

• Brand Name: SOMATOM SCOPE POWER (DE)
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- CT; siemensstr. 1- or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1; or rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 16585371
• Report Number: 3004977335-2023-64740
• Device Sequence Number: 1688329
• Product Code: JAK
• UDI-Device Identifier: 04056869013053
• UDI-Public: 04056869013053
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K183548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10046799
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 12/08/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown