Catalog Number SW10497 |
Device Problem
No Audible Alarm (1019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the receiver had intermittent audio alert on the mobile app.No data was provided for evaluation.Confirmation of the allegation and a probable cause could not be determined.No injury or medical intervention was reported.
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Manufacturer Narrative
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(b)(4).H2: correction.Mfr (3004753838-2021-165815) was reported in error.Please disregard initial reporting of this event as this event has now been deemed not reportable.
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Event Description
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Subsequent to the initial mdr, it was determined that a report was submitted in error.Upon further review, it was determined that the patient allegation does not meet the criteria of a reportable event.
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Search Alerts/Recalls
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