ST. JUDE MEDICAL ENSITE VELOCITY CARDIAC MAPPING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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Model Number EE3000 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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One ensite velocity¿ system velocity amplifier was received into the lab for analysis.Visual inspection of the returned product confirmed all input and output connectors are free of physical damage and all labeling is legible and correctly oriented.Power was applied to the returned amplifier which successfully completed the post (power on self-test) and the system status light changed to green.System log files form the reported event date of (b)(6) 2020 were reviewed which revealed random qbs errors for the catheter amplifier boards in slots 4, 7 and 9.A full functional test was performed during the evaluation period and no faults, errors or changes in system status were observed.Based on the information provided to abbott and the investigation performed, the root cause of the reported event could not be conclusively determined as no abnormalities were identified.
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Event Description
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During an afl ablation procedure, after using the amplifier for 1.5 hours, an amplifier error appeared on the ensite.While troubleshooting, it was noticed that the amplifier was flashing amber.After power cycling the amplifier twice, the light was solid amber.The procedure was aborted due to the reported issue.There were no adverse patient consequences.The patient is in stable condition.
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