Catalog Number 60000000 |
Device Problems
Circuit Failure (1089); Defective Component (2292)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/25/2024 |
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.H3 other text : the device was not returned.
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Event Description
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It was reported that the arctic sun device have alarm 72(non-recoverable system error primary outlet water temperature sensor out of range ¿ low resistance) and outlet monitor temperature (t1) was short.They would replace the tank harness in house.Parts and pricing provided.
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Event Description
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It was reported that the arctic sun device have alarm 72(non-recoverable system error primary outlet water temperature sensor out of range ¿ low resistance) and outlet monitor temperature (t1) was short.They would replace the tank harness in house.Parts and pricing provided.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause identified as a tank harness failure.They would replace the tank harness in house.Parts and pricing provided.All good faith attempts have been made to obtain additional information.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.Dhr is not required as this is not an out-of-box failure.The labelling review is not required as the complaint or 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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Search Alerts/Recalls
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