Model Number 1515 |
Device Problem
Suction Problem (2170)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/19/2022 |
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 customer reported low to no suction in the unknown eye of a patient with two patient interfaces, timing was unknown.There are multiple related reports for this facility.This report addresses a pi's (b)(4) and additional manufacturer reports will be filed.
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Manufacturer Narrative
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A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A sample was not received at the production site and insufficient information was provided; therefore, the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).
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Event Description
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There are multiple related reports for this facility.This report addresses a pi's ((b)(6), (b)(6)) and additional manufacturer reports will be filed.
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Search Alerts/Recalls
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