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Model Number FSESL |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.Patient demographics not obtained at this moment.
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Event Description
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As reported, with this foresight sensor measurement showed 90 on the forehead when the value expected was 70-80.No error message was displayed.It was tried different area of the same patient, and even on different persons.There was no allegation of patient injury.The device was available for evaluation.Patient demographics not obtained.
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Search Alerts/Recalls
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