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

Model Number	10762471
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the detailed investigation of the reported issue.The cable holder of the dcs (display ceiling stand) fell down.The analysis of the provided pictures and the investigation of the returned cable trolley showed that the edge of the groove that should hold the snap ring was broken.Therefore, the snap ring failed which led to the roll was not held in place anymore and slipped off the bearing.This led to the cable trolly falling.The visual check of the roll also revealed wear and tear as well as some larger damages.The determined damages are not related to normal use.Lateral force must have been applied to the cable trolley.In general, only movements in the direction of the rail are allowed to avoid forces that are applied from the side.Typical lateral forces would be pulling the cables sideways (by hand, or by a movable device in the room) or other kind of impact on the pulley.The affected cable trolley was already replaced at customer site.The replacement solved the issue.Shs internal post market surveillance does not indicate a general problem with the spare part.Furthermore, the maintenance instruction was checked and found to be adequate.Since no general problem is known the complaint is closed with this statement and without further measures.
Additional Manufacturer Narrative
E1: the reporting facility phone number is (b)(6).H3, h6: initial actions (corrective and/or preventive): currently no general problem has been detected for the installed base which requires an immediate action.Manufacturer's preliminary results and conclusion: it was identified that the snap ring that keeps the roll of the cable holder in place was not fastened correctly, because the groove in which the snap ring sits was damaged.Therefore, the cable hose holder could fall down.The root cause for the damaged snap ring groove has not been determined yet.Investigation is ongoing.A supplemental report will be submitted to the fda if additional information is found upon the completion of the investigation.
Event or Problem Description
Siemens healthineers became aware of an issue with the luminos drf max system.It was communicated to siemens healthineers that a corrugated cable holder of the display ceiling stand fell.No one was in the room when the assembly fell, therefore, no injury occurred.It is assumed that in a worst-case scenario, a serious injury could result from the falling assembly if the event were to reoccur.

• Brand Name: LUMINOS DRF 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: 20470978
• Report Number: 3004977335-2024-00121
• Device Sequence Number: 15321322
• Product Code: OWB
• UDI-Device Identifier: 04056869009155
• UDI-Public: (01)04056869009155
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: 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: 10/08/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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