Model Number 1515 |
Device Problem
Suction Problem (2170)
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Patient Problem
Insufficient Information (4580)
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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 ten patient interfaces (pi) lost suction.Additional information has been requested.There are multiple related reports for this facility.This report addresses patient interface #3 and other manufacturer reports will be filed.
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Manufacturer Narrative
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A review of the device history record was traceable to the reported lot number indicating that the product was processed and released according to the product¿s acceptance criteria.The root cause cannot be identified conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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