Model Number 27692 |
Device Problem
High Readings (2459)
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Patient Problem
Anemia (1706)
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Event Date 07/13/2022 |
Event Type
malfunction
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Event Description
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The customer reported inaccurate high sphb values compared to a competitor device and lab results.When the lab test (conducted 2 days post use of the masimo device) indicated the patient's sphb was too low, the hospital decided to admit the patient.The patient received a blood transfusion.
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Manufacturer Narrative
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Additional manufacturing narrative: 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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Manufacturer Narrative
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Additional manufacuring narrative: other, other text: the monitor involved in this case was not returned for evaluation.The involved sensor was returned and evaluated.During evaluation the sensor passed all visual and functional testing.The sensor passed continuity testing using a tester and also passed accuracy tests.The customer's complaint regarding accuracy was not duplicated.Additional information: h6 event problem and evaluation codes, h10 additional manufacturer narrative h3 other text : device not returned.
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Event Description
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The customer reported inaccurate high sphb values compared to a competitor device and lab results.When the lab test (conducted 2 days post use of the masimo device) indicated the patient's sphb was too low, the hospital decided to admit the patient.The patient received a blood transfusion.
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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.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 high sphb values compared to a competitor device and lab results.When the lab test (conducted 2 days post use of the masimo device) indicated the patient's sphb was too low, the hospital decided to admit the patient.The patient received a blood transfusion.
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Search Alerts/Recalls
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