SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX TRANSTAR TRANSDUCER SINGLE MONITORING KIT; PROBE, BLOOD-FLOW, EXTRAVASCULAR
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Catalog Number MX9505T |
Device Problems
Unable to Obtain Readings (1516); Failure to Recalibrate (1517)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/03/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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 while preparing to use a pressure sensor to monitor central venous pressure, it was found that the monitor had no normal waveform after the pressure sensor was connected to the lead wire.At the same time, it could also not be adjusted to zero.The same problem occurred after replacing the lead wire multiple times, but eventually the display showed up normally.There was no patient involvement and no harm/adverse event reported.
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Manufacturer Narrative
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One device was received for investigation.The device was functionally tested.During the testing, the device failed the electrical test.The reported complaint is confirmed.The main electrical board was damaged, and the pressure sensor is faulty.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
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Search Alerts/Recalls
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