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

Model Number	10742326
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom force ct system.It was reported that table movements caused a patient to become pinned between the gantry and table.It is unclear at this time if the patient suffered an injury or if an employee was injured, and the nature of that injury.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.Contrary to the initial information that a patient was injured, investigation revealed that a technologist was affected during this reported event and there was no injury to the patient.The technologist was standing between the patient table and gantry to support the patient's head during patient positioning on the table.During this, another nurse in the scanning room accidentally stepped on the food switch and held it, causing the table movement downwards.While lowering the table, the technologist's thighs became pinched and pushed down, causing the technologist to fall back against the gantry.The technologist was on restricted duty for the rest of the day.As per our knowledge the technologist did not suffer any injury.The system worked as specified, therefore, this situation is rated as an unintended accident.There are multiple warnings in the instructions for use, covering such situations.Refer to document print number hc-c2-058.621.10.02.02, chapter 2 safety information, paragraph 2.3.1 patient table, page 65: caution - lowering the patient table! body parts can get caught.Make sure that the patient¿s body parts are above the patient table.Make sure that neither body parts of anybody nor any object are below the patient table.Refer to document print number hc-c2-058.621.10.02.02, chapter 2 safety information, paragraph 2.3.6 during system movements, page 88 ff.: caution - unexpected movement or malfunction of the system or equipment! injury to patient or personnel.Damage to system or equipment.Caution - malfunction of the system or the equipment! injury to patient or personnel, unintended radiation exposure or damage to the equipment.Press a stop key at any unintentional system movement and in any hazardous situation.Press the emergency off key if the system does not respond to stop keys in any hazardous situations.Further on page 92 f.: contusion points at the gantry and patient table are clearly marked, especially the area where the technologist was located during the event.

• 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.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 18490872
• Report Number: 3004977335-2024-00001
• Device Sequence Number: 7056715
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/16/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown