Model Number N/A |
Device Problem
Wireless Communication Problem (3283)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/12/2019 |
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 signal loss over one hour occurred.It was determined that the signal loss was related to the mobile application.No product or 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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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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Manufacturer Narrative
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(b)(4).3004753838-2019-110709 was reported in error.Please disregard initial reporting of this event as this event has now been deemed not reportable.
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Search Alerts/Recalls
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