ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM GENCONNECT CABLE, FIBEROPTIC, SC/SC 100FT; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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Model Number 42-04659-002 |
Device Problems
Break (1069); Device Handling Problem (3265)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/11/2019 |
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.Further information regarding the event were requested but not received.
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Event Description
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During a procedure, the fiber optic cable connecting the ampere to dws was damaged when stepped on during the procedure troubleshooting included attempting to reconnect, switching the connector, and switching the adapter box but the issue did not resolve.There was no replaceable product and the dws could not display the ampere parameters.The procedure was cancelled and there were no patient consequences.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.A review of inspection results for this lot number confirmed that no non-conformances were identified related to the reported event and the product met abbott specifications.
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Search Alerts/Recalls
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