During the cryoablation procedure, it was noticed that a soft bang was heard followed by light smoke.The amplifier was then switched off and an attempt was made to restart it, without success.The procedure could be completed normally as the amplifier was not needed for this procedure.
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Additional information: d9, g3, h2, h3.One ensite velocity¿ amplifier was received for evaluation.Visual inspection revealed the front panel ports, chassis, and labels were free of physical damage.Visual inspection of the rear, the internals and the power input module revealed there was ingress of a liquid (saline), that entered into the rear of the chassis, and then shorted the power input module hot to ground.The power input module was physically damaged from an electrical source.Power was bypassed using a known good power input module and the amplifier passed power-on-self-test (post).The amplifier went status ready ¿green¿ and communicated with the test ensite computer.Evaluation of the board status showed all boards status were green indicating passing results.The power inductor was noted to pass the evaluation, however, evaluation also recommends to replace the ac power inductor.Both fuses were tested and were successful.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 of the event was attributed to ingress of a liquid to the power input module, from an undetermined event.
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