Model Number MODEL 250 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2015 |
Event Type
malfunction
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Event Description
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Analysis was completed on the returned programming handheld.No anomalies associated with the handheld operating system were identified during the analysis.The handheld performed according to functional specifications.Analysis was completed on the returned programming software.An analysis of the returned flashcard identified that its memory had been corrupted.As a result of the corruption, the installation and vns files were no longer accessible.A cause for the memory corruption is unknown and could not be determined.Once the flashcard was formatted and new installation software was installed, the flashcard performed with no observed anomalies.
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Event Description
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Additional information was received that the issue experienced was that the vns software was not showing upon start-up, only the handheld desktop.It was reported that this issue only occurred once.The issue was isolated to the programming handheld.It was reported that the issue occurred regardless of whether the handheld was plugged into a wall outlet or not.There is no known trauma or bad storage conditions for the handheld.The programming handheld and software have been received by the manufacturer for analysis; however, analysis has not been completed to date.
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Event Description
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It was reported that the vns programming handheld is malfunctioning.Attempts to obtain additional relevant information have been unsuccessful to date.The handheld is expected to be returned for analysis, but has not been received to date.
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Manufacturer Narrative
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Event Description
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An internal discussion between quality engineering and software engineering discovered that the software file corruption is believed to be the result of the user removing the software flashcard from the programming handheld, and then inserting it into another computer, at which point the files were intentionally (by user) or unintentionally (by computer) manipulated.In support of this, product analysis verified proper functionality of the handheld and the flashcard itself, and showed that once the files were reinstalled, there were no issues.
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Search Alerts/Recalls
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