SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR PRESSURE MONITORING SYSTEM; PROBE, BLOOD-FLOW, EXTRAVASCULAR
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Model Number MX9505T |
Device Problems
Leak/Splash (1354); Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/23/2021 |
Event Type
malfunction
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Event Description
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It was reported that before the operation started, the sensor was prepared but failed to detect arterial blood pressure.The pipeline drops water, the joint is not well sealed.The unit was replaced, calibrated and measured, which was successful.No patient injury was reported.
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Manufacturer Narrative
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A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Search Alerts/Recalls
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