Model Number 4000 |
Device Problem
Low Readings (2460)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Additional manufacuring narrative: 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 root showed saturation at 87%, the sensor was changed to an ear probe and it measured at 100%.No consequences or impact to patient were reported.
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Event Description
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The customer reported that the root showed saturation at 87%, the sensor was changed to an ear probe and it measured at 100%.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. , corrected data: d.1 was reported as rd rainbow lite set-1 adt, actual is rd set adt d.2 was reported as mwi, actual is dqa d.4 was reported as 10843997011720, actual is 10843997009567.
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Search Alerts/Recalls
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