Model Number 1515 |
Device Problem
Suction Problem (2170)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/25/2020 |
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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An optometrist reported suction was lost with a patient interface.Additional information has been requested.
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Manufacturer Narrative
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No serial number was identified with this complaint, therefore the manufacturing documentation was not reviewed.All product and batch history records are quality reviewed prior to product release.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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