Catalog Number IAP-0700 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2023 |
Event Type
malfunction
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Event Description
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It was reported "ac3 failed to pump when trying to initiate support.Purge failure alarms".To complete continue therapy, the pump was switched.No patient injury or consequence reported.The patient's current condition is reported as "fine".
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported "ac3 failed to pump when trying to initiate support.Purge failure alarms".To complete/continue therapy, the pump was switched.No patient injury or consequence reported.The patient's current condition is reported as "fine".
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Manufacturer Narrative
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Qn# (b)(4).The reported complaint of helium pressure dropped could not be confirmed upon investigation of the returned sample.The customer returned an ac3 helium regulator assembly for investigation.Visual inspection of the helium regulator assembly was performed, and no abnormality was noted.The returned helium regulator passed visual and functional test specifications.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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