Model Number 1859 |
Device Problem
High Readings (2459)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
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Event Description
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The customer reported high spo2 readings compared to blood gas.No consequences or impact to patient were reported.
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Event Description
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The customer reported high spo2 readings compared to blood gas.No consequences or impact to patient were reported.
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Manufacturer Narrative
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Additional manufacturing narrative: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing. during simulation testing, the sensor passed manual and preset conditions and provided accurate measurements.The sensor was determined to be functioning as designed. .
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Search Alerts/Recalls
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