SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR SINGLE MONITORING KIT; PROBE, BLOOD-FLOW, EXTRAVASCULAR
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Catalog Number MX9505T |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Other text: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.If the product is returned, the manufacturer will reopen this complaint for further investigation.
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Event Description
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It was reported that when using the device with a patient, it was found that the sensor value drifted and could not be normally used.After several calibrations, the value would always drift upwards and was thus replaced with a new sensor.No patient adverse event.The product's usage was stopped on (b)(6) 2023.
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Search Alerts/Recalls
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