Model Number 2414 |
Device Problems
Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/23/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Additional manufacturing narrative: the product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.
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Event Description
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Patient 1 of 3.The customer reported: "multiple sensor failures with r125l rainbow sensors losing sphb measurements during use.Error message reads ¿spo2 only".Sensors work as expected initially, then 1-2 hours after surgery begins lose all rainbow measurements (sphb and spmet) giving ¿spo2 only" message.Or environment during cardiothoracic surgery and cardiopulmonary bypass on infants around 3-10 kgs, with normal skin tones and moderate but adequate perfusion.Patients are under sterile drapes with no access to sensors during surgery".No consequences or impact to patient was reported.
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Manufacturer Narrative
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Additional manufacuring narrative: other, additional manufacturing narrative (if other): two (2) sensors were returned and evaluated.During evaluation the sensors passed all visual and functional testing.The sensors were determined to be functioning as designed.
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Search Alerts/Recalls
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