MAUDE Adverse Event Report: SIEMENS GMBH AXIOM ARISTOS FX; STATIONARY X-RAY SYSTEM

Model Number 7414803

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

The customer was informed not to use the system until the tube stand is exchanged.The concerned part was requested for further investigation.A supplemental report will be submitted if additional information becomes available.This report was submitted may 4, 2016.(b)(6).

Event Description

A siemens engineer was dispatched to the customer site to check a misalignment of the tube on the axiom aristos fx system.Upon a closer examination the engineer found out that only 2 screws on the tube stand were holding the tube and the other 2 screws were loose.There are no injuries related to this event.The reported event occurred in (b)(6).

Manufacturer Narrative

The investigation of the received part (telescope with drive) showed that no loctite had been applied by the supplier.Furthermore the screws showed oleaginous areas, which is an indication of a missing step in cleaning process.In order to prevent such failures the supplier created an instruction for production on how to use loctite.It is also known that in 2008 analysis of control samples was performed and a systematic issue could be excluded.Furthermore this topic is a part of system maintenance ((b)(4)).This report was submitted october 18, 2016.

• Brand Name: AXIOM ARISTOS FX
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS GMBH; 127 henkesstrasse; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS GMBH; 127 henkesstrasse; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern 19355 ; 6104486478
• MDR Report Key: 5631766
• MDR Text Key: 44900804
• Report Number: 2240869-2016-39773
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7414803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other