Model Number 18266 |
Device Problem
High Readings (2459)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/1901 |
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 phone # exceeded the maximum allowable characters, phone # is as follows: (b)(6).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 device was measuring too high during a routine check.No patient impact or consequences were reported.
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Manufacturer Narrative
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Additional manufacturing narrative: the returned device was evaluated.Visual inspection found the optical detector lens was recessed.During accuracy testing, the unit measured outside of the specification.A zeroing calibration was performed and the following measured value was outside of accuracy specification.The recessed optical detector lens results in co2 measurements outside the accuracy specification.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.Initial reporter phone # exceeded the maximum allowable characters, phone # is as follows: (b)(6).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 device was measuring too high during a routine check.No patient impact or consequences were reported.
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Search Alerts/Recalls
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