Model Number 6000-010-000 |
Device Problem
Intermittent Communication Failure (4038)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2021 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure at the user facility the device was inaccurate.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
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Event Description
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It was reported that during a procedure at the user facility the device was inaccurate.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
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Manufacturer Narrative
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Device evaluation: follow-up report submitted to document device evaluation results.
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Search Alerts/Recalls
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