It was reported that the arctic sun device has a black screen issue.Per follow up information received via email on 18apr2024, they repaired the device on the customer site.The issue was resolved.There was black screen problem.Replaced a control panel.Tested the device, but the flow was zero.They replaced a circulation pump.
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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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