Model Number TABLETOP-JAPAN |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported that during a procedure, the system froze.The system was rebooted to complete the case.There was a 30 minute delay, however, there was no patient harm.
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Manufacturer Narrative
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The system was examined and the reported event was not replicated.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The system met specification.Therefore, the root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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