Model Number MCP0.0703309 |
Device Problems
Device Displays Incorrect Message (2591); Insufficient Information (3190)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/19/2015 |
Event Type
malfunction
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Event Description
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It was reported that one of the rpm 20's ran at full speed momentarily.This happened just after the case while emptying the vent lines.No reported patient effect.(b)(4).
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Manufacturer Narrative
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A supplemental medwatch will be submitted when additional information becomes available.(b)(4).Both products are components of the hl20 integrated perfusion system cleared under 51(k) k943803.
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Manufacturer Narrative
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Field safety technician has been investigated and found failure reported.He added the grounding and no further instances since then.Thus the failure could be confirmed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.
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Search Alerts/Recalls
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