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 10/05/2021 |
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 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 damaged ch stress relief.The device fails functional testing, does not draw power or communicate with interfacing test fixture with cable bending at the ch connector.Device was observed through x-ray imaging and a wire was observed to be broken near the ch connector.The device was not able to obtain measurements due to broken wire inside ch connector.Results in loss of power and communication with cable bending.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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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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Search Alerts/Recalls
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