Model Number 1515 |
Device Problem
Suction Problem (2170)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/05/2020 |
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 suction was popping off.Additional information has been requested.
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Manufacturer Narrative
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A review of the device history record (dhr) 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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