Model Number 4253 |
Device Problem
Sensing Intermittently (1558)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/08/2022 |
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.
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Event Description
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The customer reported the cable is not working and stopped reading.No consequences or impact to patient were reported.
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Manufacturer Narrative
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Additional manufacuring narrative: other, other text: a total of three cables were returned and evaluated.Two cables passed all visual and functional testing and were functioning as designed.Continuity testing of the last remaining cable revealed an open connection in the cable on the white conductor, inside the bend relief area of the db9 connector.Functional testing of the last remaining cable revealed a "sensor off patient" error message was displayed on the lab monitor.
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Event Description
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The customer reported the cable is not working and stopped reading.No consequences or impact to patient were reported.
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Search Alerts/Recalls
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