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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 06/20/2022 |
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).A 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 encore device was returned for investigation.Analysis of returned product revealed that gauge needle was between 0 atm and 26 atm when received, consequently confirming the event reported.During functional testing, the yellow knob was difficult to activate.No further issues were noted.
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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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