MASIMO - 15750 ALTON PKWY KIT, EMMA CAPNOGRAPH, MMHG; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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Model Number 27803 |
Device Problem
High Readings (2459)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2023 |
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., other, other text: initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6); initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).Device not returned.
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Event Description
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The customer reported the "etco2 value is much higher than expected." 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.The completed failure analysis determined incorrect zeroing resulted in co2 measurements outside the accuracy specification.Performing zeroing restored accuracy.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).
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Event Description
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The customer reported the "etco2 value is much higher than expected." no patient impact or consequences were reported.
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Search Alerts/Recalls
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