Catalog Number 8065990941 |
Device Problem
Suction Problem (2170)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/24/2018 |
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.Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.(b)(4).
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Event Description
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A surgical coordinator reported a patient with suction loss after raster prior to the side cut during flap creation.The treatment repeated the side cut only with a new suction ring.There was no patient harm.
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Manufacturer Narrative
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Failure analysis shows the reported problem cannot be reproduced with the returned patient interface.No deviation of docking or other issues can be detected.No problem was found with the patient interface.The reported problem cannot be confirmed.No problem with the returned patient interface can be identified.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The root cause could not be identified conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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