Catalog Number 5000-01-02 |
Device Problem
Insufficient Heating (1287)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/16/2024 |
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 was making loud noise when functioning and water was staying cold and not heating up.
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Event Description
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It was reported that the arctic sun device was making loud noise when functioning and water was staying cold and not heating up.
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Manufacturer Narrative
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The reported issue was unconfirmed.The root cause of the reported issue could not be determined as the reported issue could not be reproduced.The reported event was unconfirmed, therefore dhr review was not required.The reported event was unconfirmed, therefore labeling/packaging review was not required.Correction: d, h 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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