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

Model Number 10762471

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/31/2022

Event Type  malfunction  

Manufacturer Narrative

A facility contact name was not provided to siemens.Siemens has initiated an investigation of the reported issue and the investigation is on-going.The root cause has not yet been determined.A supplemental report will be submitted if additional information becomes available.Internal id# (b)(4).

Event Description

It was reported to siemens that the patient table hit the floor while the user was moving it into the patient transfer position in preparation for an upcoming examination.There was no patient involvement, and no injury was sustained by the user.It is assumed that in worst case scenario, serious crushing injury may occur if patient or operator gets caught between the system and the floor.The user is responsible for assuring that no collision takes place while moving the system.There are corresponding notes in the operator manual.A serious injury due to the described issue has not been reported to siemens as of the date of this report.This event has been reported with an abundance of caution because the cause of the issue has not been identified yet.The reported event occurred in (b)(6).

Manufacturer Narrative

The reported issue was investigated in detail.According to the submitted information the table hit the floor during system movement.The investigation of the log files showed that the system had a positioning problem that led to a movement block for some movements.The user was informed about system movement problems with corresponding messages at the display, confirmed these messages and tried to move the system continuously.After further movement problems the user activated the "override-button" for further movements.In this case the system moves only with slow speed because the collision detection of the system is no longer active.By ignoring the displayed error messages and applying the override function for movements without collision detection, it was possible for the user to move the table into collision with the floor.According to the information received by the service technician the right rear bottom edge of the table frame collided with the floor.No parts were damaged or needed to be replaced.The issue (deviation of potentiometer values) was corrected at customer site by service technician with home and end position adjustment.Additionally, a functional test was performed to check the whole system functions without further problems.The complaint is closed without further measures.Internal id# (b)(4).

• 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; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14652433
• MDR Text Key: 295480738
• Report Number: 3004977335-2022-31246
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869009155
• UDI-Public: 04056869009155
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• 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: 08/22/2022
• 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