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

Model Number	08098027
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During screening of customer reported issues to the chinese authority nmpa on january 28, 2024, siemens healthineers became aware that an adverse event occurred while operating the somatom definition as ct system.On (b)(6) 2024, it was reported that an unconscious patient was positioned on the ct table with support from the patient's family members and also brought back to the hospital bed after the successful scan.The patent¿s family noticed abnormalities and informed the attending physician.Evaluation discovered the patient had a fracture to his left upper arm.The patient was not an emergency patient, regardless that he was unconscious.As to our knowledge the patient is currently still hospitalized for treatment.
Additional Manufacturer Narrative
Siemens healthineers was not notified of this event and was not called for any service.As the event occurred some time ago, there is no possibility for a deeper technical investigation, except for the completed customer interviews.Based on the given information we cannot prove that the ct scanner caused or contributed to the patient injury but it is rated as unlikely if regular obligations for fixation and patient monitoring during the scan were followed, as recommended in the instructions for use, especially for unconscious patients.This report is filed with an abundance of caution.

• Brand Name: SOMATOM DEFINITION AS
• 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: 18721309
• Report Number: 3004977335-2024-00020
• Device Sequence Number: 5525340
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K230421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: 08098027
• Device Catalogue Number: 08098027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Initial 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: Male