Model Number IRC5PO2V |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Should additional information become available, a supplemental record will be filed.
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Event Description
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Dealer stated that the units green light did not activate to indicate that the unit was producing o2.
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Manufacturer Narrative
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Product was returned for evaluation.The return fields in (b)(4) state: stationary concentrators.Other, other/defective.Reported problem no light/loose hardware on (b)(4).Complaint was confirmed.The underlying cause is loose hardware on (b)(4).Root cause could not be determined after reviewing the documentation in this investigation.
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Event Description
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Product was returned for evaluation.The return fields in (b)(4) state: stationary concentrators.Other, other/defective.Reported problem no light/loose hardware on (b)(4).Dealer stated that the units green light did not activate to indicate that the unit was producing o2.
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Search Alerts/Recalls
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