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

Model Number	10430603
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthineers has started a thoughtful investigation of the reported event.Despite several questions about the circumstances of the event, no information has been shared by the hospital.The evaluation of shared pictures indicates that there must have been an external force pushing the sealing ring towards the moving parts of the gantry, while it was rotating.This caused the sealing ring to become damaged and taken out of its regular position.This external force could have been caused by the patient, pushing any body parts (e.G.Arm, elbow, knee,.) against the sealing ring, if the patient is not fixed on the table, or by any bearing material that was forgotten in the gantry bore.Both situations are covered in the instructions for use, print number c2-030.620.10.02.02: in section a.2-8: caution: unintentional patient movement! contusion of patient extremities at patient table and gantry.Always fix and observe the patient during system movements.In section b.6-2: caution: use of the head-arm support! increased risk that the gantry might collide with the arms of the patient.Always keep an eye on the patient during table movements.In section a.2: caution: improper patient positioning! possible injury of the patient by moving parts.[¿] - use positioning aids as described.¿ using accessories: if you use accessories, ensure that the following objects will not collide with the gantry: - head holders and table top extension, - supports, - optional accessories, e.G., baby mattress.Damaged parts have been exchanged and the system was handed back to the customer fully operational.The hardware is not available to siemens for evaluation as it was disposed of by the hospital.The material consumption in relation to the installed base is monitored by the capa process and was within acceptance thresholds for the past three months.Therefore, no further investigation within the complaint process is deemed necessary as no systematic or design issue is to be determined.Based on all available information, the system did not malfunction and a handling related issue is the most likely root cause.This report is filed with an abundance of caution.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom definition flash ct system.The user reported that during an examination on (b)(6) 2024, the sealing ring in the middle of the gantry was damaged.The patient was not injured.

• Brand Name: SOMATOM DEFINITION FLASH
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843231631
• MDR Report Key: 20245145
• Report Number: 3004977335-2024-00115
• Device Sequence Number: 7397830
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: (01)04056869006963
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K230421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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: 10430603
• Device Catalogue Number: 10430603
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown