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Model Number 2760 |
Device Problem
Failure to Zero (1683)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/27/2022 |
Event Type
malfunction
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Event Description
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It was reported that the pressure did not return to the initial pressure (0 atm).An encore 26 advantage kit was selected for use.During the procedure, the device was inflated at 26 atm.Upon deflation, the balloon was in negative pressure, however, the manometer remained at a pressure of 26 atm and did not return to the initial pressure of 0 atm.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.The gauge needle was at 24 atm when received.A non-transparent fluid (whitish) and thick was observed inside the syringe and in the flexing tube.Complete functional testing was not possible due to the obstruction in the flexing tube.A hard density material was observed inside the flexing tube & syringe upon x-ray inspection.
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Event Description
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It was reported that the pressure did not return to the initial pressure (0 atm).An encore 26 advantage kit was selected for use.During the procedure, the device was inflated at 26 atm.Upon deflation, the balloon was in negative pressure, however, the manometer remained at a pressure of 26 atm and did not return to the initial pressure of 0 atm.No patient complications were reported.
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Search Alerts/Recalls
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