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

Model Number	11574100
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	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers was made aware that the screw securing the cable holder to the ceiling rail became loose.This caused the holder and the cable to drop down from the ceiling.The holder was reattached according to the installation instruction.No injury was communicated in this case.In worst case the issue might lead to a minor to serious injury if a person were hit by the falling parts, should the issue recur.
Additional Manufacturer Narrative
H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: the holder was reattached at the affected site.Currently no general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: the reason for the screw securing the cable holder to become loose has not yet been determined yet.The investigation is ongoing.A supplemental report will be submitted if additional information becomes available upon completion of the investigation.
Additional Manufacturer Narrative
H3, h6: siemens healthineers investigated the complaint issue in detail.It was initially stated that the corrugated hose holder fell from the ceiling.The investigation of the provided pictures show that the retaining plate of the corrugated hose holder was mounted upside down.The clamp was mounted on the bottom side of the plate.If the retaining plate is attached in this incorrect orientation, the screw which is provided to attach the plate to the transversal carriage of the ceiling tube would be not long enough to hold the plate sufficiently.It cannot be ensured that enough turns of the thread of the screw go into the nut to hold the plate securely.A picture of the nut and screw showed that locking varnish (loctite) was used as described in installation instruction.Residue of loctite or tuflock is visible on the screw and in the thread of the nut.The cable hose holder arrives preassembled in the xp factory.In the xp factory the 3d tube stand gets assembled for the system test.The hose holder is not normally removed from the hose.After the system test the corrugated hose holder remains on the hose and is packed for shipment to the customer.At the customer site the corrugated hose holder will be attached again at the transversal carriage.There is normally no need to disassemble the retaining plate during installation at the customer site.All actions are performed by trained personal.Nevertheless, it is assumed that during one of the previously described work steps, or further service activities, a workmanship error occurred which led to the retaining plate being incorrectly mounted.It was not possible to find out during which work step the holder was attached upside down.The factory team was informed about this case to create awareness about the importance of the correct mounting.The retaining plate of the complaint system was flipped to the correct orientation and reinstalled by service engineer.He also confirmed that loctite was applied to the screw.The complaint is closed with this statement.
Additional Manufacturer Narrative
H11 corrected data: d4: udi number was reported in correct format per fda request.

• Brand Name: LUMINOS LOTUS 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: 18273873
• Report Number: 3004977335-2023-00160
• Device Sequence Number: 6014638
• Product Code: OWB
• UDI-Device Identifier: 04056869269931
• UDI-Public: (01)04056869269931(21)10112
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/05/2024

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: 11574100
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 06/05/2024; 08/04/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 06/05/2024; 08/05/2024
• 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
• Patient Sex: Unknown