MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM ARISTOS FX PLUS; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number 10093864

Device Problem Device Fell (4014)

Patient Problem Eye Injury (1845)

Event Date 07/01/2022

Event Type  Injury  

Manufacturer Narrative

A facility contact name was not provided to siemens.Manufacturers preliminary analysis: the detailed circumstances regarding user workflow and potential technical aspects that led to the event and the cause for the issue are currently unknown.As of the date of this report, very little information could be provided by the customer facility.Access to the examination room and to the system is currently blocked by authorities.More detailed information was requested.Also, potentially replaceable parts were requested for investigation.The investigation is ongoing.Initial corrective actions/preventive actions implemented by the manufacturer: with the currently available information no general problem has been detected yet for the installed base which requires an immediate action.A supplemental report will be submitted if additional information is obtained.Internal id# (b)(4).

Event Description

It was reported that during an examination the axiom aristos fx plus detector fell on a patient causing a severe eye injury that necessitated surgery.The detailed circumstances regarding user workflow and potential technical aspects that led to the event and the cause for the issue are currently unknown as of the date of this report.It is not known if the patient suffered lasting eye damage.The eye injury is classified as a serious injury in this case.It is also assumed that in a similar worst-case scenario serious injury might reoccur due to the described issue.The reported event occurred in italy.

Manufacturer Narrative

H10 manufacturer narrative: h3, h6: an expert appointed by the local prosecutor's office investigated the equipment on site on two occasions.The analysis showed that the entire mechanical assembly (incl.Steel bands) was intact and did not show any mechanical or functional defects.During the second visit on-site, the column was dismantled upon request of the expert, no defects were detected.No usable logfile information was available for investigation.After the system was released by the public prosecutor for repair, to fulfil its regulatory obligations as manufacturer, siemens healthcare checked the system.No root cause for the described event could be found.Further siemens healthcare internally available information from post market surveillance did not provide new information for the cause of the incident.This complaint has been closed.H11 corrected data: h8: usage of device was incorrectly checked as "reuse" in the initial report.This field should have been blank.

• Brand Name: AXIOM ARISTOS FX PLUS
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14957406
• MDR Text Key: 295498982
• Report Number: 3004977335-2022-34793
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K061054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

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
• Device Operator: Health Professional
• Device Model Number: 10093864
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male