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 09/30/2022 |
Event Type
malfunction
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Event Description
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It was reported that the arctic sun device was failing calibration for error 103 (switch settings incorrect).Calibration testing unit (ctu) was tried on a different device and worked fine.The device was coming in for isolation circuit card replacement under warranty.Per sample evaluation results received on (b)(6) 2022, it was reported that the hot connection between the main ac power circuit card and the power inlet module shows signs of electrical overstress.Per sample evaluation results received on (b)(6) 2022, it was reported the double bend tube and the chiller evaporator outlet tube were found to be expanded during servicing.It was noted that the double-bend tube and the chiller evaporator outlet tube were replaced.
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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 the event was 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 the arctic sun device was failing calibration for error 103 (switch settings incorrect).Calibration testing unit (ctu) was tried on a different device and worked fine.The device was coming in for isolation circuit card replacement under warranty.Per sample evaluation results received on 08sep2022, it was reported that the hot connection between the main ac power circuit card and the power inlet module shows signs of electrical overstress.Per sample evaluation results received on 30sep2022, it was reported the double bend tube and the chiller evaporator outlet tube were found to be expanded during servicing.It was noted that the double-bend tube and the chiller evaporator outlet tube were replaced.
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Search Alerts/Recalls
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