INVACARE FLORIDA OPERATIONS XPO2 PORTABLE CONCENTRATOR 9153648166; GENERATOR, OXYGEN, PORTABLE
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Model Number XPO100 |
Device Problems
No Audible Alarm (1019); Out-Of-Box Failure (2311)
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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 is stating out of box failure, that there is no breath alarm will not activate, unit goes into an auto pulse mode without activation.
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Manufacturer Narrative
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Additional/updated information was added to reflect the concentrator being returned to the manufacturer for evaluation, however subsequent testing could not verify the complaint of the no breath alarm not activating.The issue was not able to be duplicated.Per the evaluation, the no breath alarm was activated in pulse mode due to the manifold leaking.Therefore, this is no longer an fda reportable event.
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Event Description
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Dealer is stating out of box failure, that there is no breath alarm will not activate, unit goes into an auto pulse mode without activation.
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Search Alerts/Recalls
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