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

Model Number 10762471

Device Problems Unintended Collision (1429); Installation-Related Problem (2965)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

A facility contact name and telephone number were not provided to siemens.Manufacturers preliminary analysis: the collision could occur because the room configuration was set incorrectly.A room height of 3m was set instead of 2.5m.Initial corrective actions/preventive actions implemented by the manufacturer: no preventive action deemed necessary as the correct proceeding for room configuration is described in the system startup instructions.No general problem has been detected for the installed base.It was requested that the user not operate the system until repair is completed.A supplemental report will be submitted if additional information becomes available.Internal id# (b)(4).

Event Description

The user tilted the luminos drf max basic unit from -90 degrees to 0 degrees and thereby drove the tube column into the ceiling rail.Damage to the system was the result.It was identified that the room configuration parameters were set to a wrong value.This wrong room configuration led to the collision of the system with the ceiling rail.No injury or patient involvement was communicated in this case.In a worst-case scenario, parts might fall due to this issue resulting in serious injury.This event is being submitted with an abundance of caution.The reported event occurred in (b)(6).

Manufacturer Narrative

The reported issue was investigated in detail.It was previously reported that when tilting the system from -90 degrees to 0 degrees with sid 150cm the tube arm hit the ceiling rail.There was no patient involvement or injuries to other persons due to the reported event.The investigation showed that the default values were set in the stand configuration (scu.Caf file), which also includes the room configuration.The default values assume a large room with no movement restrictions and a default ceiling height of 3.00m.Since the actual room height for the affected system is only 2.5m, the system movement was not restricted by the collision calculation.As a result, the ceiling rail was hit.Other configuration values stored in the scu.Caf file were checked and found to be not safety relevant.The provided log files were analyzed by the basic unit experts.The investigation showed that on 2022-02-14 at 11:30:21 due to an unknown error the scu.Caf file including the room configuration data was deleted.This is a failsafe functionality which prevents the rad controller from a reboot loop.When the scu.Caf file is present, the rad controller stays in a safe state.An error message is displayed, and the system can no longer be used.A service visit was conducted on 2022-02-14.The service engineer performed a configcheck and a completely new scu.Caf file with default room values was automatically created by the software.The originally set room configuration is part of the last backup of the system data.However, since the service engineer did not restore this backup, the system continued to use the default room configuration.The system was not checked for correct functionality before being handed over the customer.The photos of the replaced basic unit showed that the bearings of the tube column carriage and parts of the table support were damaged due to the collision.The returned basic unit was examined.The investigation confirmed that the frame was damaged by the collision.However, since it did not cause the collision, this part is not relevant for the root cause analysis.The replaced rad controller (scu-board d801) was returned for further investigation of the unknown scu error.The analysis did not reveal any errors, failures, or problem within boot-up, performance and memory.According to the information from the service organization, the damaged parts were replaced on site.The system was configured with the correct parameters including the actual room dimensions by the service organization.A constancy check was successfully performed.With this repair and corrections, the system was functional again.If the locally saved correct values (including the room configuration) are not restored during configcheck, the scu specific data is set to default.This behavior is observed by the product steering group who will decide about further measures.Furthermore, the service engineers have already been advised to always check the room configuration when performing a configcheck.To prevent system collisions caused by lost room configurations, the default room dimensions will be set to the smallest operable dimensions.This will be implemented in sw version vf11h which is planned to be released in q4/2022.The complaint has been closed.Internal id# (b)(6).

• Brand Name: LUMINOS DRF MAX
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14884230
• MDR Text Key: 295324182
• Report Number: 3004977335-2022-33562
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869009155
• UDI-Public: 04056869009155
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K173639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10762471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1