Model Number 37393 |
Device Problem
High Readings (2459)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Additional manufacturing 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., other, other text: initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).
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Event Description
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The customer reported the isa is showing 115% etco2 when ventilator settings is at 40% o2.No consequences or impact to patient were reported.
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Manufacturer Narrative
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Additional manufacturing narrative: other, other text: the returned device was evaluated.The module was left taking co2 measurements for 5 minutes using a 5% co2 gas mixture and measurement were within acceptable range.The module was left taking o2 measurements using a 51% o2 gas mixture and measurements always read 115% which means the measured value was out of range.A gas span calibration was attempted but was not successful as an error occurred.A known good o2 module was temporarily installed and the device is able to take o2 measurements.A service history record review reveals that this unit was in the field for over five (5) years with no previous reported issues related to this reported event.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).
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Event Description
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The customer reported the isa is showing 115% etco2 when ventilator settings is at 40% o2.No consequences or impact to patient were reported.
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Search Alerts/Recalls
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