Model Number 201-90411 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Power Problem (3010); Unexpected Shutdown (4019)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/24/2019 |
Event Type
Injury
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.Patient's centrimag motor is also reported under mfr# 2916596-2019-04668.
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Event Description
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It was reported that the centrimag console display screen started blinking.Flows decreased and the console display went blank.It was unsure if the flows stopped.The pump restarted but was making a grinding sound.The patient was switched to a second centrimag system.No complications.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the reported event of the console display going blank and decreased and stopped flow was not confirmed.The centrimag 2nd generation primary console was not returned for analysis.No additional information or log files were provided for review.The root cause for the reported event was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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