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

Model Number	08098027
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom definition as ct system.The customer reported on (b)(6) 2024, that on the same day, while unloading the patient, the interventional panel, which was lying in the middle of the gantry bore, was pressed thru the sealing ring.The sealing ring was broken by rotating parts and caused a bruised elbow to the patient.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The operator provided further clarification.After a ct interventional procedure with the previous patient, the operator accidentally put the intervention panel (ivp) into the bore of the ct gantry.The subsequent patient was positioned at the very top end of the table.After the scan was finished successfully, the patient table came in contact with the ivp during the unloading.The unloading is a combined horizontal and vertical movement (out and down).This contact caused the ivp to be pushed into the plexiring which was then caught by rotating parts inside the gantry.As the patient was positioned at the end of the table, the elbow was bruised.The operator confirmed the reported injury as minor and did not require any medical intervention.The patient left the hospital in a good condition.The instructions for use (print no.C2-029.620.16.03.02) cover this situation with a hint and a caution: section 4.4.2 moving the table.Information: do not place any objects underneath the patient table.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 nor any objects are below the patient table.

• Brand Name: SOMATOM DEFINITION AS
• 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: 20578348
• Report Number: 3004977335-2024-00128
• Device Sequence Number: 8170553
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: (01)04056869003665
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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: 08098027
• Device Catalogue Number: 08098027
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/31/2024
• 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 Age: 65 YR
• Patient Sex: Female