Model Number 4078 |
Device Problem
Sensing Intermittently (1558)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/01/2020 |
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.(b)(6).
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Event Description
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The customer reported spo2 dropouts during a case.No patient impact or consequences were reported.
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Manufacturer Narrative
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Additional manufacturing narrative: other text: the returned device was investigated.Visual inspection found a broken pin at the round 25 pin connector.The device failed continuity tests due to the broken pin causing an open connection.During testing, the cable malfunctioned and the error message "chk sensor" was displayed.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).
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Event Description
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The customer reported spo2 dropouts during a case.No patient impact or consequences were reported.
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Search Alerts/Recalls
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