SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR PRESSURE TRANSDUCER; PROBE, BLOOD-FLOW, EXTRAVASCULAR
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Catalog Number MX9505T |
Device Problems
Fracture (1260); Incorrect, Inadequate or Imprecise Result or Readings (1535); Tear, Rip or Hole in Device Packaging (2385); Erratic Results (4059)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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B3: the event occurred in various dates from 01-dec-2023 to 05-mar-2024.H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that no data can be detected, packaging is damaged, connector is damaged, the data is out of order, which makes the product ineffective.There was patient involvement and no patient/adverse event reported.
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Search Alerts/Recalls
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