SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR SINGLE MONITORING KIT; PROBE, BLOOD-FLOW, EXTRAVASCULAR
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Model Number MX9505T |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Other, other text: h6 codes updated.Device evaluation: no device or device photo was returned for investigation.Device history review of the manufacturing process showed no non-conformities.No actions taken at this time but complaint information will be continue to be monitored and further actions taken accordingly.
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Event Description
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It was reported that prior to use, the pressure sensor was found to be damaged.The device was replaced to resolve the issue.
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Search Alerts/Recalls
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