Model Number 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 07/23/2014 |
Event Type
malfunction
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Event Description
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Analysis of the handheld was completed on 08/25/2014.During the analysis it was identified that the handheld was unable to advance past the welcome screen.The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry.Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis.Analysis of the flashcard was completed on 08/25/2014.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.
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Manufacturer Narrative
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Device failure occurred, but did not cause or contribute to a death or serious injury.
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Event Description
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It was reported that the neurologist was having issues getting past the screen alignment screen on his handheld device.Multiple resets were performed on the handheld and the neurologist was careful to press the inside of each crosshair; however, the issue did not resolve.The handheld device was returned to the manufacturer where analysis is currently underway.
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Manufacturer Narrative
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Device manufacturing records were reviewed.Review of manufacturing records confirmed that the handheld passed all functional tests prior to distribution.Electronic submission of this report was not possible due to a problem with the manufacturer's software used for emdr submissions.
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Search Alerts/Recalls
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