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

Model Number	10762471
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: the reporting facility contact phone number is (b)(6).H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: no general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: no system malfunction has been determined based on the currently available information.The user has the responsibility to check that the patient is physically able to hold the examination position, especially when standing.There is a corresponding note in the operator manual.The customer stated that the foot support is not deep enough for this kind of examination.Additional information regarding the condition of the patient and the circumstances of the event was requested to evaluate this statement.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
Siemens healthcare was made aware that during a profile examination (lateral examination), with the table in the 90-degree position, the patient fell from the foot support and broke their knee.Additional information regarding the event has been requested but has not been received as of the date of this report.
Additional Manufacturer Narrative
Siemens healthineers investigated the complaint issue.It was initially stated that during a profile examination (understood as lateral examination) with the table in 90-degree position, the patient changed position to move face to profile according to the operator¿s order.During this, the patient fell from the foot support and fractured their knee.According to the service organization, handgrips or other positioning aids had been used.It was confirmed that the foot support was attached correctly.Based on the available information.No system malfunction was identified.The 62-year-old patient was in good health and not overweight.It is unclear why the patient fell in this case.It was stated that the patient may have moved incorrectly, and that the footrest was too small.Additional information regarding the patient¿s current health status or medical treatment provided to treat the knee fracture was not provided to siemens healthineers.The issue of patients falling from the footrest during examinations is not known as a general problem from the installed base.In general, the user has the responsibility to check that the patient is physically able to hold the examination position, especially when standing.Other positioning aids should be used when positioning the patient, especially if the patient is unstable.Furthermore, it is recommended that clinical staff should always be available to assist.It also needs to be ensured that the patient uses the handles during such an examination.This is described in detail in the system operator manual.Based on the tread surface of the footrest, it cannot be enlarged arbitrarily as this would make it even heavier.It might no longer be possible to handle and attach it safely.With the support of clinical staff during patient positioning, the current size of the footrest is the proper size to ensure both safe patient positioning and ergonomic handling.The complaint is closed with this statement and without further measures.
Additional Manufacturer Narrative
H11 corrected data: d4: udi number was reported in correct format.H11 corrected data: d4: udi number was reported in correct format.

• 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 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 18011453
• Report Number: 3004977335-2023-00140
• Device Sequence Number: 20679837
• Product Code: OWB
• UDI-Device Identifier: 04056869009155
• UDI-Public: (01)04056869009155(21)7490
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 12/06/2023; 08/04/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 12/06/2023; 08/04/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female