Catalog Number 8065750502 |
Device Problem
Intermittent Continuity (1121)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/18/2018 |
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 after a procedure, the system was shutting down on its own intermittently.
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Manufacturer Narrative
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The company service representative examined the system and was able to confirm and replicate the reported event.The nonconforming power supply was replaced.The system was then tested and met all product specifications.The system was manufactured on december 18, 2014.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to the nonconforming power supply.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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