Model Number 60000000 |
Device Problems
Insufficient Heating (1287); Overfill (2404)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
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Event Description
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It was reported that the arctic sun device came down for not warming the patient.A functional check showed that the device was overfilled.
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Manufacturer Narrative
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Per investigator evaluation, bd has determined that this mdr event is not reportable.The device was not returned.
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Event Description
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It was reported that the arctic sun device came down for not warming the patient.A functional check showed that the device was overfilled.
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Search Alerts/Recalls
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