Model Number 27977 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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.Zip code is as follows: (b)(6).
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Event Description
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The customer reported the device will turn off on it's own.No consequences or impact to patient were reported.
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Manufacturer Narrative
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Additional manufacuring narrative: the returned device was evaluated.During evaluation the device passed all visual and functional testing.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 the device will turn off on its own.No consequences or impact to patient were reported.
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Search Alerts/Recalls
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