Model Number 101/860/080 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Day of event unknown.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.
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Event Description
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It was reported that the pilot balloon and the part of the line connecting it were broken.Replacement measures were taken immediately.The event occurred in (b)(6) 2024.This occurred during patient use, no patient harm reported.
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Manufacturer Narrative
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H3 and h6 - evaluation codes: updated.Device evaluation: the product used on the patient was not returned.An unopened sample of the same lot was returned.The investigation of the complaint was limited because another sample from the same lot was returned.Under visual inspection we noticed that inflation line was not detached from pilot balloon as reported by customer.The complaint could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.This issue will continue to be monitored and further actions taken accordingly.
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Search Alerts/Recalls
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