Model Number 09-1462-0056 |
Device Problem
Communication or Transmission Problem (2896)
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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 the final report.Further information regarding the event were requested but not received.
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Event Description
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During device preparation, the workmate was switched on, and it was found that the host and the amplifier could not be connected.The issue was not resolved by restarting the amplifier and replacing the network cable.The procedure was cancelled without any adverse consequences to the patient.
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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.Based on the information received, the cause of the reported incident could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
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Event Description
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Further information confirmed that the patient was not prepped for the procedure when it was cancelled.
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Search Alerts/Recalls
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