Model Number 66021496 |
Device Problems
Device Emits Odor (1425); Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2021 |
Event Type
malfunction
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Event Description
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It was reported that a renasys go has a smoke smell.As this was noticed in a non-therapeutic environment, there was not any patient involved.
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Manufacturer Narrative
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H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Search Alerts/Recalls
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