Model Number MODEL 250 |
Device Problems
Failure to Align (2522); Operating System Becomes Nonfunctional (2996)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/01/2014 |
Event Type
malfunction
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Event Description
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An analysis was performed on the returned handheld and the reported allegation was not verified.No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge.The handheld performed according to functional specifications.
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Manufacturer Narrative
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Suspect device lot #, corrected data: the supplemental report #1 inadvertently did not report this information.
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Event Description
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The suspect device was received by the manufacturer for analysis.However, analysis has not been completed to date.
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Manufacturer Narrative
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Manufacturing device history records were reviewed.Review of the handheld device history records confirmed all quality specifications were passed prior to distribution.
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Event Description
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It was reported that the physician reported that the handheld device was malfunctioning.It was reported that the physician was unable to align the screen.Troubleshooting, including hard resets, reportedly did not resolve the issue.A replacement device was provided to the site.The handheld and related software has not been received by the manufacturer to date.It was also reported that the handheld screen was freezing upon interrogation, which is reported in mfg report #: 1644487-2014-02795.
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Search Alerts/Recalls
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