Catalog Number 2000-03 |
Device Problem
Inaccurate Flow Rate (1249)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2022 |
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.
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Event Description
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It was reported that during functional check revealed there was low flow on the arctic sun device.The calibration error 1 (pre-warm bypass flow error) timeout appeared.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.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 during functional check revealed there was low flow on the arctic sun device.The calibration error 1 (pre-warm bypass flow error) timeout appeared.Per follow information received via email on 25aug2022, the device failed the stk/mtk per follow up information received via email on 28aug2022, they just dropped mtk/stk during the technician's test.There was no patient involvement.
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Search Alerts/Recalls
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