MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM LUMINOS DRF; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 10094200

Device Problem Mechanical Problem (1384)

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

Event Date 09/05/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported incident.A supplemental report will be filed upon completion of the investigation.Internal id # (b)(4).

Event Description

It was reported to siemens that following an examination on the axiom luminos drf, the x-ray technician moved the ceiling hanging monitors away.Once the system reached the end of the rail, the stopper detached, and the cable hangers fell off.Siemens local service engineer inspected the concerned unit and corrected the issue.However, the engineer noticed that all four stoppers had been installed incorrectly.There are no injuries attributed to this event.The reported incident occurred in the united arab emirates.

Manufacturer Narrative

The issue was investigated in detail.The investigation of the provided pictures confirmed that the rail stops (bumpers) had been installed incorrectly.The two allen head screw bolts must be placed in the holes at the rail according to the installation instruction xpd0-100.812.01.03.02 (page 14 and 15).It is possible that if the rail end stops had been incorrectly mounted due to continuous usage and mechanical impact at the bumper the screws moved and fell out of the rail.However, no other cases have been reported from the field.According to local service technician, during system repair he noticed that all four stoppers had been installed incorrectly, as none of them went into the screw hole for the stopper.All of them left a mark in the outer part of the hole indicating improper installation.The requested installation report could not be provided due to the system installation had been performed by a third-party service provider several years prior.Therefore, it is not possible to clarify if the mounting was performed according to the installation instruction.The training certificate of the third-party service engineer who installed the system was requested but could not be provided.According to the service history of the device, yearly maintenance was performed as specified.The rail stop check was passed as well.However, it is not possible for service technician to detect incorrect mounting by checking if the stopper is tightened enough with the clamping screws during maintenance.The correct mounting of the stopper should be inspected during system installation and maintenance by checking the distance from cut edge to center of the blind holes.The reported event is the only occurrence that siemens is aware of; it is not considered a general problem for the installed base.It is assumed that the issue was caused by a workmanship error.To evaluate whether this issue is a general workmanship error or an isolated case, it was requested to inspect five systems installed by this third-party provider.All systems were mounted correctly, which indicates that there is no general problem.The described issue at the concerned site was solved by service technician with correct mounting of the stopper.

• Brand Name: AXIOM LUMINOS DRF
• Type of Device: IMAGE-INTENSIFIED 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: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 12449085
• MDR Text Key: 272167087
• Report Number: 3004977335-2021-96020
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K062623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094200
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other