Model Number 2760 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B3 date of event was estimated based on the initial notification date as the event date was not reported.The device was returned for analysis.Visual inspection revealed the gauge needle was at 10 atm when received and was unable to be returned to 0.The device presented a contrast media in the tube.Functional testing could not be performed due to the device was unable to be returned to 0.
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Event Description
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It was reported that a device issue occurred.An encore 26 advantage kit was selected for use.During the procedure, it was noted that the inflator was unable to function properly.No patient complications were reported.However, device analysis revealed the gauge could not zero.
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Manufacturer Narrative
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B5 describe event and problem and g3 bsc aware date: corrected.B3 date of event was estimated based on the initial notification date as the event date was not reported.The device was returned for analysis.Visual inspection revealed the gauge needle was at 10 atm when received and was unable to be returned to 0.The device presented a contrast media in the tube.Functional testing could not be performed due to the device was unable to be returned to 0.
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Event Description
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Reportable based on device analysis completed on 30nov2023.It was reported that a device issue occurred.An encore 26 advantage kit was selected for use.During the procedure, it was noted that the inflator was unable to function properly.No patient complications were reported.However, device analysis revealed the gauge could not zero.The device was returned for analysis.Visual inspection revealed the gauge needle was at 10 atm when received and was unable to be returned to 0.The device presented a contrast media in the tube.Functional testing could not be performed due to the device was unable to be returned to 0.
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Search Alerts/Recalls
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