Model Number 26971 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/1901 |
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.
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Event Description
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The customer reported inaccurate readings.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.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 inaccurate readings.No patient impact or consequences were reported.
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Search Alerts/Recalls
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