MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH LUMINOS AGILE; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 10502200

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

Due to insufficient information, the reported issue is currently not fully understood and it is being reported in doubt.Siemens is conducting a thorough investigation of the reported incident.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

Some intermittent issues with the luminos agile system were discovered.Digital imaging tower (dit) was flickering, and the patient table was moving in a strange way.It was further stated that the customer reports that the table was moving without given command.There are no injuries attributed to this event.

Manufacturer Narrative

The issue was investigated in detail.Intermittent issues with flickering leds on the left digital imaging tower (dit) control module and strange movements of the table were reported.Furthermore, short unintended table movements in longitudinal direction (head to toe) were communicated as well.For a deeper analysis further data and detailed information about the workflow was requested , however, only log files were provided.According to the information received from the service technician the "dit control module left side" (10408907) was replaced and following the repairs the issue has not reoccurred.Since the mentioned movements cannot be triggered with the buttons on the left and right dit control module, system experts were consulted to analyze the issue.According to our experts, no software problem could be identified by log file analysis.The hardware-experts assumed a very unlikely scenario based on a defective dit control module (caused by fluid inside the module), which could interfere with the ir io board (d80) and lead to the described system behavior.Though, the possibility of such occurrence is extremely low, and siemens is not aware of any similar cases.The affected part was disposed following the replacement.Therefore, the affected part was no longer available for root cause analysis.According to the provided information, the concerned system was repaired by replacing the affected part.

• Brand Name: LUMINOS AGILE
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• 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: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 12952180
• MDR Text Key: 288816575
• Report Number: 3004977335-2021-06700
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10502200
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 05/20/2022
• Supplement Dates FDA Received: 05/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other