Model Number MT20649-3 |
Device Problem
Inappropriate or Unexpected Reset (2959)
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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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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the receiver initialized without a manual restart occurred.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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It was reported that the receiver initialized without a manual restart.The product was evaluated.An external visual inspection was performed and failed.A receiver charge and boot was performed and passed.A functional test was performed and passed relevant testing.A receiver download was performed and no data was provided for evaluation.Confirmation of the allegation and 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).
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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 initialized without a manual restart.The product was evaluated.An external visual inspection was performed and passed.A receiver charge and boot was performed and passed.A receiver download was performed and passed.A functional test was performed and passed relevant testing.The receiver case was opened, and an internal visual inspection was performed and passed.The allegation was not confirmed.The probable cause could not be determined.No additional event or patient information is available.
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Search Alerts/Recalls
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