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 08/25/2022 |
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 the biomed told that the nurse had issues with low flow in arctic sun device.Biomed was able to confirm no flow and no inlet pressure.Device had 9895 system hours and coming in for the 2k preventive maintenance.Per biomed communication on 28-mar-2022, it was stated that there was no patient involvement during the reported event.The device was coming in for 2k service and repair.Per sample evaluation results received on 25-aug-2022, it was noted that the double bend tube to the manifold, chiller evaporator outlet tube was found to be expanded.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr event is not reportable.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 biomed told that the nurse had issues with low flow in arctic sun device.Biomed was able to confirmed no flow and no inlet pressure.Device had 9895 system hours and coming in for the 2k preventive maintenance.As per biomed communication on (b)(6) 2022, it was stated that there was no patient involvement during the reported event.The device was coming in for 2k service and repair.As per sample evaluation results received on 25aug2022, it was noted that the double bend tube to the manifold, chiller evaporator outlet tube were found to be expanded.
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Search Alerts/Recalls
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