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Model Number ENSITE-AMP-02 |
Device Problem
Failure of Device to Self-Test (2937)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2024 |
Event Type
malfunction
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Event Description
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At the start of a supraventricular tachycardia procedure, the amplifier booted to a solid amber color which caused a delay.Multiple reboots were attempted but issue persisted.The amplifier was rebooted with no connections in the front of the amplifier, but issue persisted.One final reboot was attempted with no cables except the power cable, which did not resolve the issue.The procedure was completed using a non abbott system (carto).
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Manufacturer Narrative
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Additional information: d9, g3, h2, h3 one ensite x amplifier was received for evaluation.Visual inspection revealed the front ports, rear ports, and chassis were free of physical damage.For evaluation purposes the port 3 and port 4 small form-factor pluggable (sfp) were temporarily exchanged.The amplifier was powered on and never initiated, then went to a solid orange ¿not-ready¿ light emitting diode (led) status.This indicated the amplifier did not start the power-on-self-test (post).It was noted that a nios message appeared against slot 3 cardiamp board, as well as a sideplane ¿state unknown¿ message.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, the root cause was attributed to the cardiamp board in slot 3 and the sideplane.
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Search Alerts/Recalls
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