Catalog Number 5000-01-01 |
Device Problem
Insufficient Cooling (1130)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that the arctic sun device did not cool water.As per follow up information received on 29sep2022, the device was in facility waiting to be sent in for repairs.Chiller was reported as the failure by technicians.
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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.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that the arctic sun device did not cool water.As per follow up information received on 29sep2022, the device was in facility waiting to be sent in for repairs.Chiller was reported as the failure by technicians.
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Search Alerts/Recalls
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