Model Number V3.0 |
Device Problem
Computer Software Problem (1112)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/16/2019 |
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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The customer reported that a software issue was observed which resulted in the machine freezing.This occurred before a procedure.There was no patient impact.There were no error messages displayed.
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Manufacturer Narrative
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The system was examined and the reported event was replicated.The lithium battery was found to be non-conforming and was subsequently replaced to resolve the issue.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to lithium battery.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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