MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH 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	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 reason that the bumper fell off the rail is still under investigation.The root cause has not yet been determined.Siemens healthineers will submit a supplemental report if additional information is obtained upon completion of the investigation.H6: component code 4755 was utilized for the bumper component.
Event or Problem Description
Siemens healthineers was made aware of a potential product problem involving the luminos dfr max system.When the user moved the tube stand, a bumper at the end of the rail fell to the floor.The bumper serves as a mechanical end stop.There was no patient involvement and no injury occurred to the user.It is assumed that in a worst-case scenario, a minor to serious injury may result if the issue to recur and a person was hit by the falling part.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the detailed investigation of the reported issue.It was initially communicated that when the user moved the tube stand, a bumper at the end of the rail fell to the floor.The bumper serves as a mechanical end stop.There was no patient involvement and no injury occurred to the user.The investigation showed that the affected mechanical end stop had not been installed correctly.The installation protocol was checked but did not show any abnormalities.It must be assumed that the affected end stop was not checked properly.It was not possible to determine why this end stop was incorrectly installed.Motorized movement is not possible because it is a semi-motorized tube stand.It can only be moved manually by the user.Furthermore, the tube stand could not have fallen out of the ceiling rail since two end stops are installed on each side.The affected end stop was not damaged and could be properly reinstalled by the local service technician.The three other mechanical end stops were checked.It was confirmed that these were installed correctly.The complaint has been closed.

• 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 HEALTHINEERS AG; siemensstrasse 1; or rittigfeld 1; forchheim 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19335 ; 4843234198
• MDR Report Key: 19181109
• Report Number: 3004977335-2024-00045
• Device Sequence Number: 7431057
• Product Code: OWB
• UDI-Device Identifier: 04056869009155
• UDI-Public: 4056869009155
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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: 04/23/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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