ST. JUDE MEDICAL, INC ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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Model Number EE3000 |
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 10/18/2021 |
Event Type
malfunction
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Event Description
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During a 3d case, a communication issue occurred and the procedure was cancelled.Following mapping of the left ventricle, before the first ablation, the ensite stopped and connection with the amplifier was lost.The dws and amplifier were reset, however the amplifier still had a flashing orange light and the procedure was cancelled.
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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 did not pass power-on-self-test (post).The amplifier went status not-ready blinking ¿amber¿ and communicated with the test ensite computer.Evaluation of the board status showed the electro-cardiogram (ecg) board was not available.The error logs had temperature and voltage out of range conditions which confirms the reported symptom.The reported event was able to be duplicated by power sequencing and evaluation of the logs.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 confirmed, and the root cause was attributed to the electro-cardiogram board in slot 4.
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