Model Number 3577 |
Device Problem
Sensing Intermittently (1558)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2021 |
Event Type
malfunction
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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.
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Event Description
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The customer reported shortages in the cord then it stopped working over the weekend.No patient impact or consequences were reported.
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Event Description
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The customer reported shortages in the cord then it stopped working over the weekend.No patient impact or consequences were reported.
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Manufacturer Narrative
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Additional manufacturing narrative: the returned device was evaluated.Visual inspection found no external damage or defects.Device functionality testing found the unit established communication with interfacing test fixture; however, the module does not communicate properly with the connected sensor.Device was observed through x-ray imaging and no defects were observed.The device is sealed and cannot be opened for internal inspection without damaging the module.Exact component failure could not be determined due to device being fully potted.A service history record review reveals that this unit was in the field for over five (5) months with no previous reported issues related to this reported event.
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Search Alerts/Recalls
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