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	Abrasion (1689)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens was informed of an incident with the luminos drf max system.A patient was brought into the examination room in a wheelchair.The patient table was in 90-degree position, with the footrest attached.The patient had difficulty getting onto the footrest and held onto the handgrip strip.Due to his weight the handgrip strip detached on one side, and the patient fell.The patient suffered some skin abrasions and bleeding, but no bone fractures.This injury is considered a minor to moderate injury.It is assumed that in worst case a serious injury might be the outcome should the issue recur.
Additional Manufacturer Narrative
E1: reporting facility contact phone number is (b)(6).H3, h6: manufacturer's preliminary results and conclusion: the root cause of the handgrip strip became detached from the patient table has not yet been determined.The service engineer found no defects on the rail of the patient table to which the handgrip is fixed or on the fixing mechanism of the grip.It is currently assumed that the handgrip might not have been fastened correctly and/or the maximum permissible weight of 20kg was exceeded.The investigation is ongoing.Initial actions (corrective and/or preventive): no general problem has been detected for the installed base which requires an immediate action.A supplemental report will be submitted to the fda if additional information becomes available upon completion of the investigation.
Additional Manufacturer Narrative
H3, h6: the described issue was investigated in detail.It was initially described that a patient was brought into the examination room in a wheelchair.The patient table was in 90-degree position, with the footrest attached.The patient had difficulty getting onto the footrest and held onto the handgrip strip.Due to the patient¿s weight, the handgrip strip detached on one side, the patient fell, and suffered bruises.The service engineer found no defects on the rail of the patient table to which the handgrip strip was attached or on the fixing mechanism of the affected part.The service engineer assumed that the handgrip strip was not attached tight enough on one side because one of the clamps was found to be bent.However, this was not confirmed by the user.The affected handgrip strip was requested as complaint part, but due to a misunderstanding the affected part was scrapped and was therefore not available for investigation.It is described in the operator manual to ensure that the patient handgrip strips are tightened before use.In general, this handgrip strip provides additional protection for the patient¿s hands when the tabletop moves.The handgrip strip is not intended to be used to pull yourself up, as the maximum permissible load is 20 kg.The affected handgrip strip (material number 10307466) was replaced on site.No further issues were communicated.Siemens healthcare internal post market surveillance does not indicate a general problem for the affected part.Based on the available information and images, no system malfunction was identified.The complaint is closed with this statement and 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: 17796041
• Report Number: 3004977335-2023-00120
• Device Sequence Number: 2149369
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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: 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: 09/14/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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