MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG LUMINOS AGILE; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 10502200

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: currently no general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: the investigation is ongoing.The cause for the detaching footrest has not been determined yet.Additional information was requested for the investigation.In general, it is recommended to check the footrest again before each use to ensure it is properly attached.The correct handling is described in the operator manual.Siemens healthineers will submit a supplemental report if additional information is obtained upon completion of the investigation.

Event Description

Siemens healthineers became aware of an issue involving the luminos agile system.During a patient examination the footrest fell off the table and the patient fell.There was no patient injury communicated to siemens healthineers.

Manufacturer Narrative

H3, h6: siemens healthineers investigated the complaint issue in detail.It was initially stated that the footrest fell off the table during an examination and the patient fell.There was no report of patient injury.According to the information from the service engineer, the footrest was attached with the table flat at 0 degrees.The issue occurred when the table was tilted to 90 degrees.The footrest detached at approximately 80 degrees.Additional information was provided that the footrest may have been damaged prior to this incident.It was slightly twisted so that the footrest was not completely flat on the table as it should be.This caused the rear head side lock to require some downward pressure (toward the table) to fully engage when the footrest was being attached.This behavior could also be seen in a video provided for the investigation.However, it cannot be determined if this twist in the footrest was present before or was caused by the detachment.According to the information from the service engineer, the affected system is heavily used.The system was installed in 2013.Provided images show heavily worn tabletop notches with burrs.However, these burrs do not affect the safe footrest attachment.In general, potential burrs on the notches should be removed during maintenance to ensure that there are no sharp edges and to support smooth handling (per the system maintenance instructions).According to the service engineer, the footrest detached because it was not fully locked in place.After the incident, the footrest could still be fully attached to the tabletop.However, due to the twist, the attachment was more difficult than usual and required additional attention and downward pressure on the part to attach it safely.Based on the available information the issue was caused by incorrect attachment of the footrest.However, it cannot be excluded that the slight twist in the footrest caused the issue.The reason for the twist could not be determined.The issue was solved on site with the replacement of the tabletop (material number 8892163) and the foot support (material number 8893385).Siemens healthineers internal post market surveillance does not indicate a general problem for the affected parts.In general, it is recommended to check the footrest again before each use to ensure it is properly attached.The correct handling is described in detail in the operator manual.To further improve the understanding of how to use the footrest, the description in the operator manual has been updated with additional details and illustrations on how to securely attach the footrest.The improved operator manual is available since 03/2023.For the installed base, an addendum for the improved understanding of the handling of the footrest had been released on (b)(6) 2022 with (b)(6).The affected customer received the addendum in j(b)(6) 2023.The complaint is closed with this statement and without further measures.

• Brand Name: LUMINOS AGILE
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• 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: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 18967392
• MDR Text Key: 338606452
• Report Number: 3004977335-2024-00035
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10502200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1