Model Number 50000000E |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2022 |
Event Type
malfunction
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Event Description
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It was reported that there was no flow when the arctic sun device was tested.A functional check showed that the circulation pump could not generate more than -2.0 psi.Per follow up information received on 20-july-2022, there was no patient involvement as the event was found during testing.Per sample evaluation result received on (b)(6) 2022, it was reported that control panel disc drive was failure during assessment.Double bend tube and chiller evaporator outlet tube were found expanded during servicing.Tanks seals were found lifted from the tank.
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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 event is not reportable. 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 there was no flow when the arctic sun device was tested.A functional check showed that the circulation pump could not generate more than -2.0 psi.As per follow up information received on 20july2022, there was no patient involvement as the event was found during testing.As per sample evaluation result received on 02dec2022, it was reported that control panel disc drive was failure during assessment.Double bend tube and chiller evaporator outlet tube were found expanded during servicing.Tanks seals were found lifted from the tank.
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Search Alerts/Recalls
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