Catalog Number 60000000 |
Device Problem
Circuit Failure (1089)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/28/2024 |
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.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 booted to an alarm 72 (non-recoverable system error- primary outlet water temperature sensor out of range ¿ low resistance).Discussed this was indicative of a shorted t2 thermistor.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause of the reported issue is a failed t2 thermistor.The device was evaluated upon receipt.A dhr is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.The reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.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 booted to an alarm 72(non-recoverable system error- primary outlet water temperature sensor out of range ¿ low resistance).Discussed this was indicative of a shorted t2 thermistor.
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Search Alerts/Recalls
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