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

Model Number	10430603
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens performed a thorough investigation of the reported event.In november 2023 it was noted that the system's right front cover of the patient handling system (phs) was completely broken exposing the distance bolt and the tabletop support wheels.A proposal for repair was provided to the customer who elected to not approve the repair.Siemens informed the customer that the system should not be used.A second repair proposal was made in june 2024 which again was not approved by the customer until 12nov2024.Currently the customer has confirmed not to use the system until repair which is currently planned for early december 2024.As stated in the owner¿s manual, print number c2-030.620.10.02.02: section a.1-11 "general safety information": damage and defects: damage or defects which occur to the system (patient table, gantry), to add-ons or accessories can result in an unsafe operation.Watch out for such damage and have these parts repaired or replaced immediately.Section 1-3 "general safety information" safety guidelines the guidelines for safety and use are defined in this manual.Read the manual carefully and observe the instructions.This applies especially to guidelines that deal with function tests, mechanical safety and radiation protection.Caution not observing the operator manuals of the system, system options and accessories! injury of the patient.Follow the safety instructions.Summarized the root cause for the incident was an improper and unsafe condition of the scanner, well known and accepted by the customer.No systematic product or design issue was identified, so no further measures are deemed to be necessary.
Event or Problem Description
It was reported to siemens that an injury to a patient occurred on (b)(6) 2024 while using the somatom definition flash in brazil.The patient was scheduled for a chest ct, abdomen ct and a sinuses ct.At some point during one of those exams the patient hit her left hand on a part of the patient handling system (phs) which was uncovered and cut her fourth finger.It is unclear if this happened prior to the patient receiving any radiation or not.The patient injury was treated by local physicians and an x-ray of her hand was necessary.Patient received three stiches on her fourth finger of the left hand and an administered a high dose of an unspecific antibiotic.The patient was discharged from the hospital after two days of the incident, but it is unclear if the stay was caused by the injury or by after care for the transplant.

• Brand Name: SOMATOM DEFINITION FLASH
• 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: marion mints ; 40 liberty blvd; malvern, PA 19355 ; 4843231632
• MDR Report Key: 20787126
• Report Number: 3004977335-2024-00137
• Device Sequence Number: 15448813
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: (01)04056869006963
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: 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: 10/29/2024
• Initial Report FDA Received Date: 11/26/2024
• 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 Sex: Female