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Model Number 1410AG |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/20/2021 |
Event Type
malfunction
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Event Description
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It was reported that with 2% sevoflurane input, the board measures only by 1.3%.With 2% isoflurane input, it measures by 2%.Agent xcal in sevoflurane on the factory service menu shows unusual value such as 114.Iso xcal offset shows unusual value at 10831.No adverse patient effects were reported.
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Manufacturer Narrative
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This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-11204.The report was submitted in error.
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Search Alerts/Recalls
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