Model Number 50000000 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that the arctic sun device had a failed heater, and the customer would like to send the device in for service.Per follow up information received on 04mar2022, there was no patient involvement during reported event.Per sample evaluation result received on 12aug2022, the unit was full of brown water upon receipt.Tank seals were torn.And the double bend tube and the chiller outlet l tube were expanded.
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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 of 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 had a failed heater, and the customer would like to send the device in for service.Per follow up information received on 04mar2022, there was no patient involvement during reported event.Per sample evaluation result received on 12aug2022, the unit was full of brown water upon receipt.Tank seals were torn.And the double bend tube and the chiller outlet l tube were expanded.
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Search Alerts/Recalls
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