Model Number 3449 |
Device Problem
Sensing Intermittently (1558)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2022 |
Event Type
malfunction
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Event Description
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The customer reported intermittent connection or not working at all.No patient impact or consequences were reported.
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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.Device not returned.
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Manufacturer Narrative
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Additional manufacuring narrative: other text: the returned device was evaluated.During functional testing, the module intermittently did not draw power or communicate with interfacing test fixture with cable bending at the ch connector.Testing confirmed an electrical open at wire breaks inside ch bend relief.The wire breaks resulted in loss of function.
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Event Description
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The customer reported intermittent connection or not working at all.No patient impact or consequences were reported.
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Search Alerts/Recalls
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