Model Number 25054 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2021 |
Event Type
malfunction
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Event Description
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The customer reported that the hemoglobin was inaccurate.No consequences or impact to patient were reported.
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Manufacturer Narrative
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The device has not been returned to the investigation facility to allow for an analysis to be performed.If the product is received for evaluation or new information is obtained, a follow up report will be submitted.
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Manufacturer Narrative
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Additional manufacturing narrative: the returned device was evaluated.During evaluation the device passed all visual and functional testing.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.
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Event Description
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The customer reported that the hemoglobin was inaccurate.No consequences or impact to patient were reported.
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Search Alerts/Recalls
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