Model Number XPO100 |
Device Problem
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, dealer stating that the auto pulse failed and did not alarm at 5lpm for no breath detected.
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Manufacturer Narrative
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Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The result of the evaluation was the sensitivity restrictor tubing on the pcb needed to be adjusted for the breath alarm to function as intended.
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Event Description
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Dealer is stating out of box failure, dealer stating that the auto pulse failed and did not alarm at 5lpm for no breath detected.
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Search Alerts/Recalls
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