MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH LUMINOS DRF MAX; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10762471
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer narrative: the customer facility phone number is (b)(6) a customer facility contact name was not provided for reporting purposes.This issue was discovered by a siemens healthcare customer service engineer.Initial corrective actions/preventive actions implemented by the manufacturer: the rails will be replaced at the affected site.It was recommended to the customer facility to not use the foot board until the rails have been replaced.No general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: it was communicated that the user changes the position of the foot board on the rails several times per day.This might have had an impact on the widening of the holes, but the exact root cause is not determined yet as the investigation is ongoing.A supplemental report will be submitted to the fda if additional information becomes available upon completion of the investigation.
Event or Problem Description
During service activities it was noticed by the siemens customer service engineer (cse) that the holes on the rails into which the foot board is locked are wider than expected.The cse confirmed that the foot board can be safely fixed to the patient table currently.However, if the issue was not noticed during the service activities, it cannot be excluded that the holes would have eventually become more worn out over time, and the attachment of the foot board would have become unsafe.In a worst-case scenario, if the foot board would detach from the patient table during an examination, a minor to serious injury might occur.
Additional Manufacturer Narrative
H3, h6: the described issue was examined in detail.The affected patient tabletop was sent back as complaint part and investigated by experts for the basic unit.It was determined that the worn-out holes were not manipulated.The wear was caused only from the attachment, detachment.And movement of the foot board.According to the service organization the customer specific workflow requires to move the foot board by sliding between different mounting positions on the foot side of the tabletop very often.The bolt of the locking mechanism of the foot board left scratches in the aluminum.The bolt is made of steel and therefore harder than the aluminum rail.When the bolt reaches the hole, it slides in.With every slide into the hole the edges of the holes become curved out a bit more.The experts tested the complaint part regarding safe attachment of a foot board.The foot board was still attachable without problems.A weight test with 230kg on the foot board was performed.The foot board remained safely attached.This is the first known issue with such heavily worn-out mounting holes at the tabletop.Shs internal post market surveillance also does not indicate a general problem.Since no general or systematic issues were identified.The complaint is closed without further measures.

• Brand Name: LUMINOS DRF MAX
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; 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: 17361558
• Report Number: 3004977335-2023-00063
• Device Sequence Number: 6091306
• Product Code: OWB
• UDI-Device Identifier: 04056869009155
• UDI-Public: 04056869009155
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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: Other
• Device Model Number: 10762471
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/26/2023
• 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