Model Number 50000000 |
Device Problems
Defective Component (2292); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/02/2023 |
Event Type
malfunction
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Event Description
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It was reported that an error occurred in an arctic sun device.Replaced the device and performed the case.The details of the error were under investigation.Case completed on replaced machine.Per review of wo on (b)(6) 2023, there was no impact to the patient.Per follow up information received via email on (b)(6) 2023, the device was under investigation.
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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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Manufacturer Narrative
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The reported issue was confirmed.The root cause was isolated to a faulty control panel.The device was evaluated and the reported issue was confirmed as there was a control panel failure noted.Control panel (40308200) replacement and calibration and function check.Unit was evaluated for functionality.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 not an out of box failure and therefore the reported event is not manufacturing related.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.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that an error occurred in an arctic sun device.Replaced the device and performed the case.The details of the error were under investigation.Case completed on replaced machine.Per review of wo on 04may2023, there was no impact to the patient.Per follow up information received via email on 08may2023, the device was under investigation.
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Search Alerts/Recalls
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