Model Number 7414803 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/14/2016 |
Event Type
malfunction
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Manufacturer Narrative
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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).
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Event Description
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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).
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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