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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT EVHRS NON-INVASIVE HEART REFERENCE SENSOR

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EDWARDS LIFESCIENCES CLEARSIGHT EVHRS NON-INVASIVE HEART REFERENCE SENSOR Back to Search Results
Model Number EVHRS
Device Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2016
Event Type  malfunction  
Manufacturer Narrative
The product has been returned for evaluation; however, the evaluation is in progress. Upon receipt of the evaluation results a supplemental report will be submitted. The device history record review was completed and all manufacturing inspections passed with no non-conformances and the product met all specifications upon distribution.
 
Event Description
It was reported that while the clinician was setting up, prior to patient use, the evhrs unit (heart reference sensor) would not adjust for height changes after zeroing. When the evhrs unit was zeroed the blood pressure reading was appropriate. When the hrs unit was raised above heart level, the blood pressure did not decrease as expected. When the hrs unit was lowered below the heart level, the blood pressure did not increase as expected. There were no error messages observed. The suspect evhrs unit was exchanged for another evhrs unit and the same steps were followed and then the evhrs unit responded appropriately. There was no patient involvement. There was no patient harm or injury.
 
Manufacturer Narrative
One ev1000ni heart reference sensor was received for product evaluation. The examination found that the evhrs unit was able to perform zeroing in any relative position. When the ft2 functional and calibration tester was performed on the unit, the hrs unit failed the test. An x-ray was performed on the unit and there were multiple breaks found on the internal flat flex cable. The flat flex cable connects the dpt sensor to the printed circuit board internally. The damaged flat flex cable is consistent with the unit having been twisted or strained during use. The device service history record review was completed and all manufacturing inspections passed with no non-conformances. The complaint was confirmed by evaluation. Although the root cause of the damage cannot be conclusively determined, handling factors may have contributed to the issue. The operators manual pn 157811 appendix e states the proper handling of the unit by the user. A corrective and preventive action has been generated to address this issue.
 
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Brand NameCLEARSIGHT EVHRS
Type of DeviceNON-INVASIVE HEART REFERENCE SENSOR
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92606
Manufacturer (Section G)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
lynn selawski
one edwards way
irvine, CA 92614
9497564386
MDR Report Key5773981
MDR Text Key48923695
Report Number2015691-2016-02155
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2017
Device Model NumberEVHRS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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