SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR PRESSURE TRANSDUCER; PROBE, BLOOD-FLOW, EXTRAVASCULAR
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Catalog Number MX9505T |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Zero (1683); Inappropriate Waveform (2536); Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that the device was unable to calibrate to zero, could not produce wave forms and the waveforms "do not match the numbers".It was also reported that the protective cover where the lead wire was connected was "relatively hard"."when pulling out the lead wire, you need to press the buckle with great force to pull it out.There was patient involvement and no patient harm/adverse event reported.
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Manufacturer Narrative
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B3: date of event is unknown; no information has been provided to date.E1: reporter phone number: (b)(6).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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Manufacturer Narrative
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No device was made available for evaluation.Therefore, the reported complaint cannot be confirmed.If icu medical receives the device, we will reopen the investigation.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.
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Search Alerts/Recalls
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