Catalog Number STS-OR-001 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/30/2023 |
Event Type
malfunction
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Event Description
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It was reported that unknown device malfunction occurred.Data was evaluated and the allegation was confirmed as signal loss greater than an hour was confirmed.The probable cause was determined to be signal loss.The probable cause of the signal loss could not be determined.The reported event of an unknown device malfunction is reportable based on the finding of signal loss greater than an hour.No injury or medical intervention was reported.
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Manufacturer Narrative
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(b)(4).3191 - patient was unable to identify device issue therefore a more specific code could not be selected.4316 - the concluded cause is not adequately described by any other term.
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Search Alerts/Recalls
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