MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-CT NAEOTOM ALPHA; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	11330003
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Crushing Injury (1797)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a handling issue.The user manual was provided to the customer showing all relevant safety information as the patient was not fixated on the patient table as recommended.Additionally, the gap dimensions between the moving part and the stationary of the table were evaluated.The values were assessed by our experts and are within specification.No general design issue has been determined.Therefore, no remedial action is deemed necessary as there was no device malfunction.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the naeotom alpha ct system.At the end of an examination, during horizontal movement of the patient table, the patient´s (90 years, female) left index finger was trapped in the gap between the tabletop and table support.The patient was sent to the emergency room of a hospital that specializes in hand treatment.No further information was provided regarding the extent of the injury nor how her finger was medically treated.According to the available information the patient returned home the same day.This report has been submitted with an abundance of caution.

• Brand Name: NAEOTOM ALPHA
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 15120744
• Report Number: 3004977335-2022-35472
• Device Sequence Number: 20663540
• Product Code: JAK
• UDI-Device Identifier: 04056869263168
• UDI-Public: 04056869263168
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/28/2022

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: 11330003
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female