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

Model Number	10430603
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens became aware of an incident that occurred while operating the somatom definition flash system.Patient´s right hand was stuck in the gap between the tabletop and the table side cover during unloading the patient handling system (phs); this resulted in an injury to the patient¿s finger.The patient´s finger was cleaned and bandaged.No further medical treatment was required.Siemens service engineer checked the involved hardware, and no irregularities were observed on the phs.
Additional Manufacturer Narrative
The investigation showed that all gaps and dimensions of the table are within the specifications.This event was evaluated as a device handling issue; no general product issue could be identified based on the available information.The definition flash instructions for use (print no.C2-030.620.15.03.02; chapter 2.2.2 "system movement") contain multiple warnings.Such as: ¿ movement of the tabletop entails a danger of injury.Unintentional patient movement! contusion of patient extremities at patient table and gantry.Always fix and observe the patient during system movements.Movable parts of the ct system! possible injury of the patient by moving parts.Always observe the possible contusion points shown in the following pictures.¿ this report is being submitted with an abundance of caution.

• Brand Name: SOMATOM DEFINITION FLASH
• 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: anastasia sokolova ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234197
• MDR Report Key: 17711874
• Report Number: 3004977335-2023-00110
• Device Sequence Number: 2149174
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K190578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

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: 10430603
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 09/08/2023
• 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 Age: 76 YR
• Patient Sex: Female