Model Number TABLETOP |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/08/2020 |
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 after surgery, the system had a complete lock up.
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Manufacturer Narrative
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The company service representative examined the system was able to confirm and replicate the reported event.The company service representative reinstalled the software.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a software issue.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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