Model Number 4003 |
Device Problem
Low Readings (2460)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/29/2020 |
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 that the device provided low readings.No consequences or impact to patient were reported.
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Manufacturer Narrative
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Additional manufacuring 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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Event Description
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The customer reported that the device provided low readings.No consequences or impact to patient were reported.
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Search Alerts/Recalls
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