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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 06/20/2016
Event Type  malfunction  
Manufacturer Narrative
The product 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. The device service history record review was completed and documented that the device met all specifications upon distribution.
 
Event Description
It was reported that while monitoring a patient during a neck surgery there was a blood pressure reading discrepancy. There was a difference of 20 ¿ 30mmhg between the clearsight system and the nibp (non-invasive blood pressure). The patient also had an arterial line with a flotrac which correlated with the nibp. When the discrepancy was observed with the clearsight system, the clinician discontinued use of the system. There was no patient harm or injury.
 
Manufacturer Narrative
One ev1000ni heart reference sensor was received for product evaluation. The examination found that when the product was tested, per the final acceptance tester (fat), that the product passed the test on three separate occasions without any error messages noted. All results were normal. The ft2 calibration test was completed and the product failed the test. An x-ray was performed and it was found that there were open traces on the internal flat flex cable. The flat flex cable connects the dpt sensor to the printed circuit board inside the hrs unit. The damage is consistent with the product being twisted or strained during use. The device service history record review was completed and all manufacturing inspections passed with no non-conformances. The reported 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 product by the end user. 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 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
lynn selawski
one edwards way
irvine, CA 92614
9497564386
MDR Report Key5778621
MDR Text Key49054659
Report Number2015691-2016-02167
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2017
Device Model NumberEVHRS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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