Model Number EVHRS |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for analysis; however, it has not yet been received.Upon return of the product a supplemental report will be submitted with the investigation results.
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Event Description
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It was reported that the clearsight heart reference sensor (hrs) unit did not display the correct pressure readings during a training demonstration with rns.The hrs unit displays the pressure values based on the height difference between the heart and the finger to which the cuff is attached.This hrs did not change with height differences, therefore giving inaccurate values.There was no error message noted.The suspect hrs unit was exchanged for a different hrs unit, and the values were as expected.There are no other suspect devices involved.There was no patient involvement.
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Manufacturer Narrative
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One heart reference sensor was returned for product evaluation.The hrs unit was connected to a known good working clearsight system for analysis and testing.The sensor did not respond appropriately to differences in bladder and sensor height.The hrs unit measures values based on the height differences between the heart and the finger to which the cuff is attached.It takes into account differences in pressure between the finger and heart and compensates hydrostatic pressure changes due to differences in height between the finger and the heart.There were normal blood pressure readings that were obtained three times.The hrs unit failed the ft2 calibration test.A visual inspection of the unit was performed and there was no physical damage found and there was no oil leakage observed.An x-ray was taken and there was no internal damage found.The hrs unit was manufactured may 2016 and has been in the field for approximately ten months.The root cause of the failure is expected wear over normal use.The use life of the hrs unit is stated in the ifu as 90 days.The ifu contains several troubleshooting measures in the event there is a pressure difference, including re-zeroing, verifying hrs placement and replacing the hrs, if necessary.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported event was confirmed by product evaluation.There is no evidence or indication that a manufacturing defect is responsible for the reported event as the stated issue is thought to be expected wear over normal use.The issue will continue to be monitored as part of the monthly management review process.There is no further action that will be taken at this time.
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Search Alerts/Recalls
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