Catalog Number 8065990898 |
Device Problem
Suction Problem (2170)
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Patient Problem
No Information (3190)
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Event Date 02/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device history records (dhr) for the device were reviewed.The associated device was released based on acceptance criteria.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 a suction issue during surgery.Additional information requested.
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Manufacturer Narrative
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The root cause could not be determined conclusively without further information.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The device history records (dhr) for the product lot was reviewed.No abnormalities that could have contributed to this event were found.The sample was returned.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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Search Alerts/Recalls
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