Catalog Number 8065750502 |
Device Problems
Intermittent Continuity (1121); Unexpected Shutdown (4019)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/25/2019 |
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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A healthcare professional reported that the system intermittently switched itself off when they were testing it.There was no patient involvement as they had no surgeries scheduled for that day.
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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 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 the nonconforming power supply.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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