ST. JUDE MEDICAL, INC. ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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Model Number 600023001 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2021 |
Event Type
malfunction
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Event Description
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During an atrial fibrillation procedure, an internal error was noted when trying to connect the amplifier which caused a delay.The amplifier was rebooted multiple times which did not resolve the error message; the amplifier status light was green.An amplifier had to be borrowed from another facility to complete the procedure which caused a delay.The procedure completed with no patient consequences.
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Manufacturer Narrative
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One ensite velocity amplifier was received for evaluation.Visual inspection revealed the front panel ports, chassis, and labels were free of physical damage.Power was applied to the amplifier and the amplifier passed the power-on-self-test (post).The amplifier went status ready ¿green¿ and communicated with the test ensite computer.Evaluation of the board status revealed an impedance symptom attributed to slot 6 catheter amplifier board.Review of the logs revealed matching synchronization and impedance symptoms attributed to the same board at slot 6.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 reported event was duplicated, and the root cause was attributed to slot 6 catheter amplifier board.
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