Model Number 50000000 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/09/2023 |
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.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 monitor turned off during patient use on the arctic sun device.Per follow up information received via email on 15may2023, patient completed on an alternate machine.They did not receive any patient information.
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Manufacturer Narrative
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The reported issue was unconfirmed.The root cause of the reported issue was unable to be determined, as the reported issue could not be duplicated during evaluation.During evaluation, arctic sun device was performing to specification.Arctic sun passed all tests successfully and unit is ready to be returned to the customer.A dhr review is not required as the reported event is unconfirmed.The labeling/packaging review is not required as the reported event is unconfirmed.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 actual/suspected device was inspected.
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Event Description
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It was reported that monitor turned off during patient use on the arctic sun device.Per follow up information received via email on (b)(6) 2023, patient completed on an alternate machine.They did not receive any patient information.
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Search Alerts/Recalls
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