ST. JUDE MEDICAL, INC. ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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Model Number 600023001 |
Device Problem
Failure of Device to Self-Test (2937)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2021 |
Event Type
malfunction
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Event Description
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During the atrial fibrillation procedure, the communication was suddenly disconnected and the indicator light was flashing in orange.The system was power cycled, the power cable was exchanged and the power outlet was changed with no resolution.All the devices including the dws were power cycled, but the issue was not resolved.The issue was finally resolved after 10th attempt of power cycling, and the procedure was completed with no adverse consequences to the patient.Abbott medical japan will check the problem first and see whether this device needs to have it repaired at your side or not.
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Manufacturer Narrative
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Additional information: d9, g3, h2, h3.One ensite velocity¿ system velocity amplifier was received for analysis.No accessories or original packaging was available for inspection.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 cycled to green.System log files for the reported event date were then reviewed which indicated transport/socket errors which were resolved.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.The field reported event was unable to be reproduced; a successful functional test was then performed without error.The cause for the reported communication issue and subsequent delay remains unknown.
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Search Alerts/Recalls
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