Catalog Number CARDIAC UNKNOWN |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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Complaint was received via the berman & wedge survey negative responses.It was reported that once the catheter was in position, there were no pressure reading/waveforms acquired from the desired location.
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Manufacturer Narrative
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(b)(4).No part has returned to teleflex chelmsford for investigation.The complaint was received from a customer survey.The reported complaint of "no pressure reading/waveforms" is not able to be confirmed.The root cause of the complaint is undetermined.The complaint was received from a customer survey and the specific material/lot number was not reported.A lot number history for this account was not retrieved.If lot number information is available at a later date, the complaint will be updated accordingly.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
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Event Description
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Complaint was received via the berman & wedge survey negative responses.It was reported that once the catheter was in position, there were no pressure reading/waveforms acquired from the desired location.
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Search Alerts/Recalls
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