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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES CLEARSIGHT HEART REFERENCE SENSOR EVHRS 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 11/20/2020
Event Type  malfunction  
Manufacturer Narrative
The product has been received for product evaluation. The evaluation has not been completed. Once the findings are available, a supplemental report will be submitted. The device history record review was completed and all manufacturing inspections passed with no non-conformances. The udi information is (b)(4).
 
Event Description
It was reported that while zeroing the heart reference sensor (hrs), the offset value was at 30mmhg when it was held near level position. The device was then zeroed properly and was left to run for hours during a case. The edwards clinical field specialist was present and said that the clearsight numbers were 30 points higher than the brachial cuff numbers when he observed. The brachial cuff was reading good values for map>65mmhg. The edwards rep recalls a cycle where the brachial cuff read approximately 62mmhg for map and clearsight was reading significantly higher. Halfway through the case, the clearsight monitoring was stopped so as to move the patient for the second part of the procedure. They disconnected the patient equipment. The anesthesiologist was working to get the brachial cuff reading connected. The edwards rep was connecting the clearsight finger cuffs. They were using a dual cuff monitoring mode up until this point, but went with the single finger cuff monitoring now. The finger cuff reading was higher that the brachial cuff reading. The edwards rep re-zeroed and started the finger cuff monitoring again, but had the same issue. It was running 30 point offset higher. They exchanged the suspect hrs device and the issue was resolved. The value readings were now much closer to the forearm cuff reading. The cardiac index and svr numbers were much better than during the first part of the case. It is unclear if this was by chance or due to the replacement of the hrs. There were no error messages or alarms noted. The exact inaccurate numbers are not available as the facility does not use electronic records. There was no inappropriate patient treatment reported. There was no patient harm or injury.
 
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Brand NameCLEARSIGHT HEART REFERENCE SENSOR
Type of DeviceEVHRS 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
jessica atallah
one edwards way
irvine, CA 92614
9492500294
MDR Report Key10979942
MDR Text Key220979500
Report Number2015691-2020-14934
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 Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/09/2021
Device Model NumberEVHRS
Device Catalogue NumberEVHRS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2019
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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