ST. JUDE MEDICAL, INC. 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 10/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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During preparation with the patient on the table, the amplifier was booted up, displayed a flashing amber light and the case was cancelled.Multiple reboots were attempted, the air filter was cleaned, and a second outlet was attempted.The issue was not able to be resolved and the procedure was aborted and cancelled.
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Manufacturer Narrative
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One ensite velocity¿ system velocity amplifier was received 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.Ac power was then applied, and the returned amplifier failed to successfully complete the post (power on self-test) and the system status light remained amber.Additional analysis isolated the root cause of the reported issue to an incomplete system calibration of the catheter amplifier pca (printed circuit assembly) located in the slot 11 position.Failure to power up slot 11 was also confirmed within the system log files.The system was recalibrated, and normal functionality was restored to the system.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the root cause of the reported event has been isolated to an incomplete system calibration which resulted in the loss of the catheter amplifier board at the slot eleven location.
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Search Alerts/Recalls
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