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Model Number H700977 |
Device Problem
Failure to Analyze Signal (1539)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2021 |
Event Type
malfunction
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Event Description
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During an electrophysiological procedure, the display of live signals became delayed by approximately 30 seconds and the procedure was cancelled with no 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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information received, the cause of the reported signal issue and subsequent cancellation remains unknown.
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Search Alerts/Recalls
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