Model Number 10094137 |
Device Problems
Use of Device Problem (1670); Connection Problem (2900)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.Internal id # (b)(4).
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Event Description
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It was reported to siemens that a 3d run aborted on the artis pheno unit.The issue happened twice with two different patients.It is unclear whether any injuries are attributed to this incident.The reported issue occurred in (b)(6).
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Manufacturer Narrative
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Siemens completed the investigation of the reported event.Unfortunately, the investigation did not reveal a clear root cause.Although the returned part has been examined and the logfile has been reviewed the root cause of the error mentioned in the complaint could not be definitively determined.According to the system specialists the most proper reason is a sporadic defect of the multi display manager (mdm) which is responsible to control the large display.This thesis is supported by the fact that the system worked well after exchanging the mdm.Finally, this investigation could not show any systematic issue or even an error burst; so, no approaches for improvements could be identified.No further measures are necessary.
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Manufacturer Narrative
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In initial report date (b)(6) 2020 was reported.Corrected data is (b)(6)2020.
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Search Alerts/Recalls
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