Model Number 22042 |
Device Problems
Incorrect Measurement (1383); Sensing Intermittently (1558)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2022 |
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.(b)(6).
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Event Description
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The customer reported the device provided repeated dropouts and implausible readings.No patient impact or consequences were reported.
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Event Description
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The customer reported the device provided repeated dropouts and implausible 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., other text: initial reporter phone # exceeded the maximum allowable characters, phone # is as follows: (b)(6).
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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.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed., other, other text: initial reporter phone # exceeded the maximum allowable characters, phone # is as follows: (b)(6).
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Event Description
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The customer reported the device provided repeated dropouts and implausible readings.No patient impact or consequences were reported.
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Search Alerts/Recalls
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