Model Number 26945 |
Device Problem
Sensing Intermittently (1558)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/16/2020 |
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 the device will not hold a signal.No patient impact or consequences were reported.
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Event Description
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The customer reported the device will not hold a signal.No patient impact or consequences were reported.
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Manufacturer Narrative
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Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection showed signed of contamination on the contact points of the top shell.When powered on the device was unable to obtain readings and displayed a replace cable error message.Internal inspection showed contamination damage on the pogo pins of the rd15 sensor flex cable causing the replace cable error message.The sensor flex cable was replaced and the device was able to obtain readings.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.
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Search Alerts/Recalls
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