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

Model Number	10742326
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	07/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The patient destroyed the plexiglass ring with his knee and was not fixed during the examination.The patient should be fixed and observed at any time according to the instructions for use somatom | syngo ct vb20 (print no.Hc-c2-058.621.10.02.02, page 90, chapter 2.3.6 ¿ safety information ¿ during system movements).Caution box: unintentional patient movement! injury to the patient.Always fix and observe the patient during the measurement.Somatom | syngo ct vb20 (print no.Hc-c2-058.621.10.02.02, page 91, chapter 2.3.6 ¿ safety information ¿ during system movements).Warning box: incorrect patient positioning, unintended patient movement, and unobserved movement of the patient table or gantry! injury to the patient, for example, contusions of the patient's extremities and unusable radiation.Always fix the patient with accessories, as described in the instructions for use, to avoid unintentional patient movement.For example, use restraint straps and arm supports.Monitor the patient continuously as long as the table top and gantry are moving.Take special care if the tilt of the gantry is anything other than zero degrees or the table height is anything other than the isocenter.Make sure that nothing can get caught while the table or gantry are moving.For example, parts of the body or clothing, any needles, infusion tubes, respiration tubes, catheters, ecg cables, or sheets and blankets.Follow the markings and labels on the equipment.Press a stop key if an injury to the patient can occur.As there is no systematic or design issue identified and the system works as specified, no further measures are deemed necessary.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom force ct system.On (b)(6) 2024, a patient lifted his leg while scanning and broke the sealing ring (scan window).The patient suffered a small abrasion on his leg.The minimal abrasion did not require medical intervention and the patient was in good condition.

• Brand Name: SOMATOM FORCE
• Common Device Name: 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., mc 65-1a; malvern, PA 19355 ; 4843231631
• MDR Report Key: 19840174
• Report Number: 3004977335-2024-00091
• Device Sequence Number: 20787489
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: (01)04056869006956
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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: 10742326
• Device Catalogue Number: 10742326
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 07/26/2024
• 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 Age: 86 YR
• Patient Sex: Male