ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER; 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 11/01/2019 |
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 a subsequent submission. .
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Event Description
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During the procedure, the amplifier would display an amber light and the procedure was cancelled.Troubleshooting was attempted with no resolution.There were no adverse consequences to the patient due to the cancellation.
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Manufacturer Narrative
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One ensite velocity¿ system velocity amplifier was received for investigation.When the amplifier was powered on and had timed in, it was displaying a solid green led.Error logs and post history show the catheter amplifier board in slot 6 has failed temperature sensors several times.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 abbott specifications and procedures.Based on the information provided to abbott and the investigation performed, the root cause of the amber light and subsequent procedure cancellation was isolated to the catheter amplifier board in slot 6.
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