Model Number 1505 |
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 05/03/2019 |
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.(b)(4).
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Event Description
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A customer reported a patient interface with suction loss during treatment.Additional information requested.
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Manufacturer Narrative
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The root cause cannot be identified conclusively.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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