Catalog Number 8065750502 |
Device Problem
Computer Operating System Problem (2898)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2020 |
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 the system locked up during multiple surgeries.The system was rebooted to complete surgery.There was no patient harm.
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Manufacturer Narrative
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The company service representative examined the system and was not able to confirm or replicate the reported event.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 system was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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