Model Number PC2K |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been received for evaluation and the evaluation is in progress.Upon return of the evaluation results a supplemental report will be submitted with the evaluation findings.The device service history record review has not been completed.When the results are available a supplemental report will be submitted.
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Event Description
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It was reported that during patient monitoring with the clearsight system, there were inaccurate blood pressure readings that displayed.The issue was isolated to the clearsight pressure controller as the contributor.The system was re-zeroed and then restarted after an ¿hrs error¿ was observed.When patient monitoring re-started there was a normal waveform that appeared.The clearsight bp reading was incorrect at 60/40mmhg for a minute.The arm cuff reading was 90/50mmhg.The patient¿s condition did not change and a minute later the clearsight bp was 120/70mmhg then changed to 90/50mmhg and lastly 30/10mmhg over a fifteen-minute period.The edwards representative removed the heart reference sensor and exchanged it for another one and upon trying to re-zero, the reading was moving around to multiple numbers, even though the heart reference sensor was still.The pressure controller was removed and exchanged for another pressure controller, then everything worked without any further issues.There was no inappropriate patient treatment administered.There was no patient harm or compromise.The patient gender is male and slightly hypotensive.No other patient demographic information will be released by the facility.
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Manufacturer Narrative
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There was one clearsight pressure controller device that was returned for product evaluation.The suspect pressure controller was connected to a known good working clearsight system for analysis and functional testing.The clearsight system was able to perform zeroing successfully three times without any errors noted.There was a normal waveform and normal blood pressure readings obtained on cuff 1 and on cuff 2 without any issues.A visual inspection was performed and there was no physical damage identified on the device.There was no defect found.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported event could not be confirmed by evaluation.There is no evidence or indication that a manufacturing defect is responsible for the reported event.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.Issues such as poor finger perfusion, improperly applied finger cuff, incorrectly sized finger cuff, improper application of the hrs or failing to zero the hrs sensor may lead to inaccurate hemodynamic measurements.The operators manual instructs the use on these above stated factors that can lead to inaccurate values.There was no patient involvement.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.The udi information is (b)(4).
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Search Alerts/Recalls
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