MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG LUMINOS AGILE MAX; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10762472
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause was determined to be a use error.No general problem has been detected for the installed base which requires an immediate action.It is assumed that in a worst case a minor to serious injury might be the outcome should the issue reoccur, and the cover would fall off and hit a person.
Event or Problem Description
An event occurred while operating the luminos agile max system.While tilting the patient table to the vertical position, the operator ran the table into the display ceiling suspension (dcs) causing a cover on an arm joint to break and fall off.No injuries were attributed to the event.
Additional Manufacturer Narrative
The root cause was determined to be a user error.No general problem has been detected for the installed base which requires an immediate action.It is assumed that in a worst case a minor to serious injury might be the outcome should the issue reoccur, and the cover would fall off and hit a person.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the luminos agile max system.While tilting the patient table to the vertical position, the operator ran the table into the display ceiling suspension (dcs) causing a cover on an arm joint to break and fall off.There is no report of impact to the state of health of any patient or user involved.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the investigation for the reported issue.The detector ceiling stand (dcs) is manufactured by ondal.The position of the dcs arm was not tracked and therefore not known by the collision calculation.It is in the responsibility of the operator that equipment or other movable objects are outside of the movement path of the system.This is also described in the luminos agile max system operator manual chapter ¿system safety¿.Furthermore, if the dcs option from the manufacturer ondal is available, the installation must be performed according to the manuals provided by ondal, especially regarding the adjustment of the endstops.In general, the movement of the dcs arm can be restricted.This can help to avoid collision with the basic unit.Since no system malfunction could be determined the complaint is closed with this statement.

• Brand Name: LUMINOS AGILE MAX
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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: 20027979
• Report Number: 3004977335-2024-00101
• Device Sequence Number: 7448656
• Product Code: OWB
• UDI-Device Identifier: 04056869009162
• UDI-Public: (01)04056869009162
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2024

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
• Operator of Device: Health Professional
• Device Model Number: 10762472
• Device Catalogue Number: 10762472
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 08/15/2024; 10/10/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 08/28/2024; 10/10/2024
• 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
• Patient Sex: Unknown