ST. JUDE MEDICAL, INC. ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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Model Number 100014514 |
Device Problem
Failure of Device to Self-Test (2937)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/27/2019 |
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 the final report.
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Event Description
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At the beginning of the procedure, the orange lights on the amplifier did not switch to green, resulting in a cancellation.When switching the ensite cpu there was an error message stating that there was an amplifier error.Logging out and restarting both the amplifier and dws were performed several times but the issue persisted and the procedure was cancelled.The amplifier was replaced.There were no adverse patient consequences.
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Manufacturer Narrative
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One velocity amplifier was received for evaluation.Visual inspection revealed the connectors, switches, and labels appeared to have no physical damage.The mounting hardware was secured.Normal wear and tear was observed on the exterior enclosure.No other visible anomalies were observed.When the amplifier was powered on and had timed in, it was displaying a flashing yellow led.The current source board was not seen in board status.Error logs show slot 2 power up errors in 10 of 15 log files.The failure was duplicated in the board tester.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with specifications and procedures.Based on the information provided to abbott and the investigation performed, the cause for the reported event was due to a non functional current source board.
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Search Alerts/Recalls
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