Catalog Number 8065750502 |
Device Problems
Intermittent Continuity (1121); Loss of Power (1475)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/24/2019 |
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.(b)(4).
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Event Description
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A customer reported that the system intermittently turned off during start up.The system was rebooted to initiate surgery.
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Manufacturer Narrative
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The system was examined and the reported event was confirmed and replicated.The printed circuit board (pcb) was 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 qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a nonconforming pcb.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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