Catalog Number 5000-01-03 |
Device Problem
Insufficient Cooling (1130)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2022 |
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.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 was alarming 113 (reduced water temperature control).They got serviced and water temperature would not cool, and temperature was not dropping after 30 minutes.Per follow up information received on (b)(6) 2022, the alarm 113 (reduced water temperature control) means that actual temperature did not match the expected temperature for the system.This alarm could mean many different things and not one problem specifically.There was no patient involvement.
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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 cascading failure 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 was alarming 113 (reduced water temperature control).They got serviced and water temperature would not cool, and temperature was not dropping after 30 minutes.Per follow up information received on 30may2022, the alarm 113 (reduced water temperature control) means that actual temperature did not match the expected temperature for the system.This alarm could mean many different things and not one problem specifically.There was no patient involvement.
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Search Alerts/Recalls
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