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

Model Number 10431700

Device Problems Degraded (1153); Material Disintegration (1177)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/20/2023

Event Type  Injury  

Event Description

Siemens became aware of an incident that occurred while operating the somatom drive system.While switching from the head rest to the foot rest table extension of the patient handling system (phs), the edge of the tongue of the table extension had numerous carbon fibers that splintered off and embedded into the hand of the clinical staff member.The clinical staff member sought medical attention at the facility¿s emergency department.The carbon fibers were manually extracted under administration of lidocaine by the doctor without further issues.According to the feedback of the injured person, she is expected to heal quickly as it is ¿objectively a small (minor) injury¿.

Manufacturer Narrative

An investigation of the provided photos of the table extension was performed, and they do not indicate a general product issue.The mounting tongue of the table extension shows clearly signs of wear.Which leads to the splintered carbon fibres.Siemens has requested the hardware in order to conduct a thorough investigation of the reported event.Should the investigation identify a general design, systematic issue, or any other reason as a root cause of this issue, a supplemental report will be filed.This report is submitted with an abundance of caution.

• Brand Name: SOMATOM DRIVE
• Type of Device: 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: 18064194
• MDR Text Key: 327247718
• Report Number: 3004977335-2023-00142
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: 04056869006970
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K230421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10431700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female